BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER W/AMC THROMBOSHIELD

    MDR report key: 3191651 · Received June 26, 2013

    Report

    Report Number
    2015691-2013-20438
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    May 23, 2013
    Report Date
    May 30, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K812563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WAS RECEIVED WITH AN ATTACHED MONOJECT 1.5CC LIMITED SYRINGE AND CONTAMINATION SHIELD. BALLOON TESTING WAS PERFORMED WITH THE RETURNED SYRINGE. EXAMINATION REVEALED THAT THE BALLOON INFLATED CLEARLY AND CONCENTRICALLY AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. THE BALLOON DEFLATED IN 2 SECONDS WITHOUT THE SYRINGE ATTACHED, WHICH IS WITHIN THE ALLOWABLE SPECIFICATION. BALLOON FAILED TO DEFLATE FULLY WITH RETURNED SYRINGE ATTACHED. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. THERE WAS NO VISIBLE DAMAGE OBSERVED FROM THE CATHETER BODY OR THE RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE COMPLAINT WAS NOT CONFIRMED AND NO MANUFACTURING NON-CONFORMANCES WERE IDENTIFIED DURING THE EVALUATION. ALTHOUGH THE BALLOON MAY DEFLATE WITH THE SYRINGE ATTACHED, THE CATHETER WAS DESIGNED TO BE PASSIVELY DEFLATED WITH THE SYRINGE REMOVED. ALL SWAN-GANZ IFUS INSTRUCT THE CLINICIAN TO "PASSIVELY DEFLATE THE BALLOON BY REMOVING THE SYRINGE FROM THE GATE VALVE". AFTER DEFLATION, THE SYRINGE SHOULD BE RE-ATTACHED TO THE GATE VALVE. THE FRICTION BETWEEN THE SYRINGE BARREL AND PLUNGER MAY BE TOO GREAT FOR THE ELASTICITY OF THE BALLOON LATEX TO OVERCOME; THEREFORE, THIS IS NOT A RELIABLE METHOD FOR DEFLATION. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BEFORE USE WHEN THE BALLOON WAS TESTED, IT WAS OBSERVED THAT THE BALLOON DID NOT DEFLATE, IT APPEARED TO DEFLATE SLOWER THAN USUAL. IT WAS INDICATED THAT THE SYRINGE WAS REMOVED WHEN DEFLATING THE BALLOON. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290199 SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER W/AMC THROMBOSHIELD CATHETER, FLOW DIRECTED DYG EDWARDS LIFESCIENCES, PR 831HF75 59365844

    Patients

    Seq Age Sex Outcome Treatment
    1