BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 2022856 · Received March 17, 2011

    Report

    Report Number
    2015691-2011-15044
    Event Type
    Malfunction
    Date Received
    March 17, 2011
    Date of Event
    January 14, 2011
    Report Date
    January 17, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K812563
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AS RECEIVED, THE BALLOON WAS RETURNED BUT NOT ATTACHED TO THE CATHETER. RESIDUAL ADHESIVE WAS OBSERVED AT BOTH THE PROXIMAL AND DISTAL BONDS. IT IS UNKNOWN AT WHAT POINT THE BALLOON DETACHED FROM THE CATHETER. THE CONTAMINATION SHIELD, SYRINGE AND INTRODUCER WERE NOT RETURNED. ALL THROUGH LUMENS WERE TESTED FOR PATENCY AND LEAKAGE. ALTHOUGH IT WAS REPORTED THAT THE FAILURE OCCURRED PRIOR TO USE, DURING EVALUATION OF THE PRODUCT THE PROXIMAL INFUSION LUMEN WAS FOUND TO BE OCCLUDED WITH WHAT APPEARED TO BE BLOOD. REMAINING THRU LUMENS WERE FOUND TO BE PATENT, WITHOUT LEAKAGE OR OCCLUSION. NO VISIBLE DAMAGE WAS OBSERVED ON THE CATHETER BODY. A CAPA WAS OPENED TO INVESTIGATE THIS ISSUE. THE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER WAS PROVIDED AND A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET SPECIFICATION UPON DISTRIBUTION.EXPIRATION DATE: OCTOBER 01, 2011APPOXIMATE AGE OF DEVICE: 9 MONTHSDEVICE MANUFACTURE DATE: APRIL 12, 2010

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON WAS NOT INFLATING BEFORE USE. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER W/AMC THROMBOSHIELD CONTINOUS CARDIAC OUPTUT CATHETER DYG EDWARDS LIFESCIENCES, PR 831HF75 58856126

    Patients

    Seq Age Sex Outcome Treatment
    1