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Pleurx™ Pleural Catheter Kit Cat. 50-7000B / 50-7700

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Pleurx™ Pleural Catheter Kit Cat. 50-7000B / 50-7700 Cat. 50-7000B / 50-7700 Pleur X™ Pleural Catheter Kit For Pleural Placement Only LATEX Sterile Not made with natural rubber For Single Use Only latex. Instructions for Use USA Rx Only For product inquiries or technical assistance, please call (800) 653-6827 SafetyGlide is a trademark of Becton Dickinson and Company Filter Straw is a registered trademark of B. Braun, Inc. BioPatch and Dermabond are trademarks of Johnson & Johnson Corporation. PleurX, ChloraPrep, Hi-Lite Orange, CareFusion and the CareFusion logo are trademarks or registered trademarks of CareFusion Corporation, or one of its affiliates. © 2010, 2011, 2012, 2014, 2015, CareFusion Corporation or one of its affiliates. All rights reserved. CareFusion 75 North Fairway Drive Vernon Hills, IL 60061 USA 361-33402 • 2015-08 ContaDinEs HphP thalates DCN 60218-1 Vernon Hills, IL Proofed by: Date: R. Cisneroz 08-03-15 Dimensions checked: Copy checked: 361-33402 Figure DCN 60218-1 Vernon Hills, IL Proofed by: Date: R. Cisneroz 08-03-15 Dimensions checked: Copy checked: 361-33402 Figure (A) (A) (B) (9) (B) (4) (C) (C) (10) (5) (11) (6) 7A 7B (12) ~5 mm (7) “CLICK” (8) (13) DCN 60218-1 Vernon Hills, IL Proofed by: Date: R. Cisneroz 08-03-15 Dimensions checked: Copy checked: 361-33402 (20) (14) (21) (15) (16) (22) (17) (23) “CLICK” (24) (18) (19) (25) DCN 60218-1 Vernon Hills, IL Proofed by: Date: R. Cisneroz 08-03-15 Dimensions checked: Copy checked: 361-33402 PleurX Pleural Catheter Procedure Warnings Product Information Do not put anything except the access tip of the The PleurX Pleural Catheter consists of a fenestrated lockable drainage line, access kit, or PleurX Vacuum silicone catheter with a valve mechanism and a Bottles into the PleurX Catheter valve since any other polyester cuff. A barium sulfate stripe runs the entire device could damage the valve. A damaged valve length of the catheter. (Figure 1) The valve is may allow air into the body or let fluid leak out designed to prevent the passage of air or fluid in through the valve when not draining. either direction unless it is accessed with the Cautions specifically matched drainage line, access kit, or For single use only. Re-use may result in a vacuum bottles provided by CareFusion. The PleurX nonfunctional product or contribute to cross Pleural Catheter is designed exclusively for use with contamination. the PleurX vacuum bottle, glass vacuum bottles, and the lockable drainage line for connection to wall Sterile technique should be used when placing and suction or portable suction. draining the catheter. The fenestrations must be entirely within the pleural PleurX Pleural Catheter space to avoid leakage into the tunnel tract. Take Polyester patient size, tunnel length, and the catheter length Fenestrations Cuff Valve into account when placing the catheter. Individuals with severe skin pathology overlying the 25.5 cm 12.5 cm 28 cm favored implantation site (e.g. tumor invasion / Internal Portion External Portion psoriasis) should receive alternative treatment to Catheter: 66.0 cm relieve symptoms. (1) Sterility This product has been sterilized. It is for single use only and is not to be resterilized. Do not use if PleurX Lockable Drainage Line package is damaged. CareFusion will not be Lockable Access Tip Roller Clamp responsible for any product that is resterilized, nor accept for credit or exchange, any product that has been opened but not used. PleurX Catheter Tray Supplies Drainage Line: 61 cm Luer Lock Preparation Components (2) 2 ChloraPrep® 10.5 ml Applicators with Hi-Lite Orange™ Tint Indications for Use 1 Fenestrated Drape 1 Filter Straw The PleurX Pleural Catheter System is indicated for 3 Lidocaine HCl 1%, 5 ml Ampules intermittent, long term drainage of symptomatic, 1 SafetyGlide Needle, 22 G x 1 ½” (3.8 cm) recurrent, pleural effusion, including malignant 1 SafetyGlide Needle, 25 G x 1” (2.5 cm) pleural effusion and other recurrent effusions that do 1 Blue Wrap not respond to medical management of the underlying disease. The devices are indicated for the Placement Components palliation of dyspnea due to pleural effusion and 1 PleurX Pleural Catheter, 15.5 Fr providing pleurodesis (resolution of the pleural 1 Safety Scalpel effusion). The Drainage Line is used to drain fluid 1 Guidewire Introducer with Needle using standard wall suction, water seal drainage 2 Syringes, 10 ml system, vacuum bottle, or other appropriate method. 1 Needle Foam Stop Contraindications 1 J-tip Guidewire 1 Forceps Use of the PleurX Pleural Catheter System is 1 Dilator, 12 Fr contraindicated in the following situations: 1 Peel-Away Introducer, 16 Fr 1. When there is a shift > 2 cm in the mediastinum 1 Tunneler towards the ipsilateral side of the effusion. 1 Catheter Insertion Stylet 2. When the pleural cavity is multi-loculated, and the Closing Components drainage of a single loculation would not be 1 Tweezer expected to provide relief of dyspnea. 1 Silk Suture, 2-0 Straight Needle 3. When there is a coagulopathy. 1 Absorbable Suture, 4-0 Curved Needle 4. When the pleural cavity is infected. Drainage Components 5. When the effusion is known to be chylous. 1 Drainage Line with Lockable Access Tip The catheter insertion stylet is not designed for use 1 Needle, 17 G x 1” (2.5 cm) in the arterial system or as a hemostatic device. 1 5-in-1 Drainage Line Adapter 1 Alcohol Pad 1 Valve Cap 1 DCN 60218-1 Vernon Hills, IL Proofed by: Date: R. Cisneroz 08-03-15 Dimensions checked: Copy checked: 361-33402 Dressing Components 1. Position the patient appropriately to access the 6 Gauze Pads, 4” x 4” (10.2 cm x 10.2 cm) desired guidewire insertion site. 1 Foam Catheter Pad 2. Identify the appropriate intercostal space for 1 Self-Adhesive Dressing guidewire placement. The guidewire is typically General Guidelines placed in the sixth or seventh intercostal space. Ultrasound can be used to confirm the guidewire 1. The procedure for pleural placement can be insertion site. performed using local anesthetic and sedation. However, depending on patient needs, it may be 3. Identify the location of the catheter exit site, performed using alternative approaches to which is usually approximately 5 cm inferior and anesthesia or sedation. lateral to the guidewire insertion site. 2. Use of image guidance may aid in the accuracy 4. Surgically prep both sites utilizing the and safety of catheter placement. Care should be ChloraPrep ® applicators. Refer to the taken to identify and avoid contact with ChloraPrep insert for further information. vasculature near the guidewire insertion site. 5. Place the fenestrated drape with the opening 3. Guidewire placement site selection should be located over the planned insertion and tunneling based upon patient anatomy and presentation sites. with consideration given to any possible Caution: Use the filter straw for aspiration only. Do adhesions or loculated pockets of fluid. not use for injection. 4. Consideration should be given to the patient’s Note: Utilize a filter straw when aspirating Lidocaine ease of access in determining the location of the into the syringe. catheter exit site. 6. Aspirate the Lidocaine HCl 1% into a syringe. 5. The fenestrated end of the catheter may be cut Attach the 25 G needle to the syringe and raise a shorter depending on an individual patient’s skin wheal. Aspirate additional Lidocaine into the anatomy. Note: Leave at least one fenestration syringe and use the 22 G needle to complete present on the catheter. infiltration of the access site and tunnel track. 6. When using the drainage line, it may be used to Refer to Addendum for additional product drain at a suction level of -60 cm H 2O or less for information. as long as it takes to drain 1,000 ml of fluid from Caution: Care must be taken when inserting the the chest per day. The volume of fluid removed guidewire introducer needle to avoid puncturing or should be based on the individual patient’s status lacerating the lung or liver. and the risks for over draining, including 7. Insert the guidewire introducer with needle, reexpansion pulmonary edema in the chest. attached to a syringe, through the desired Suggested Placement Procedure intercostal space and just over the lower rib. 8. Ensure free aspiration of pleural fluid, then remove the needle and syringe, leaving the guidewire introducer in place. 9. Insert the guidewire through the introducer, advancing it well into the pleural cavity. Caution: Do not allow the guidewire to inadvertently advance totally within the patient. Ensure that the guidewire exits the proximal end of the needle, dilator, sheath or stylet prior to and during placement of each component. First Incision: 10. Remove the introducer, leaving the guidewire in Tunneled Guidewire place. portion of insertion site catheter Caution: If the needle is left in place with the Second guidewire introducer, damage to the guidewire may Incision: Catheter result if withdrawn through the needle. External portion exit site of catheter 11. Make a 1 cm incision at the guidewire insertion site. (3) 12. Make a second 1-2 cm incision approximately 5 cm inferior and lateral to the guidewire Proper medical and surgical procedures are the insertion site. This incision will be the catheter responsibility of the physician. The appropriateness exit site. Consider the patient’s ease of access in of any procedure must be based upon the needs of determining its location. (Figure 3) the patient. Figure (3) illustrates the placement of the PleurX Pleural Catheter, as described in the following procedure. 2 DCN 60218-1 Vernon Hills, IL Proofed by: Date: R. Cisneroz 08-03-15 Dimensions checked: Copy checked: 361-33402 Note: A smaller incision may provide better security 17.
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