BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ THERMODILUTION VENOUS INFUSION PORT (VIP) CATHETER WITH AMC THROMBOSHI

    MDR report key: 1905191 · Received November 22, 2010

    Report

    Report Number
    2015691-2010-14415
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    September 12, 2010
    Report Date
    September 13, 2010
    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

    CATHETER WAS RECEIVED WITH THE BALLOON LATEX MISSING FROM THE CATHETER TIP AND THE LATEX WAS NOT RETURNED. THERE WAS SOME LATEX STILL ATTACHED TO BOTH PROXIMAL AND DISTAL BOND SITES. ALL THROUGH LUMENS WERE PATENT WITHOUT ANY LEAKAGE OR OCCLUSION. CONTAMINATION SHIELD AND INTRODUCER WERE NOT RETURNED. THERE WAS NO VISIBLE DAMAGE OBSERVED ON THE CATHETER BODY OR ON THE RETURNED MONOJECT 1.5CC LIMITED VOLUME SYRINGE. IT WAS REPORTED THAT THE EVENT OCCURRED BEFORE USE; THEREFORE, A ROOT CAUSE CANNOT BE IDENTIFIED ON WHY THE BALLOON LATEX WAS MISSING. THE DIRECTIONS FOR USE INDICATE TO NOT INFLATE THE BALLOON ABOVE 1.5 ML (USE THE SUPPLIED MONOJECT 1.5CC SYRINGE), AS BALLOON RUPTURE MAY OCCUR. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND IT WAS CONFIRMED THAT THE DEVICE MET SPECIFICATIONS UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BALLOON RUPTURED 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 WITH AMC THROMBOSHI THERMODILUATION CATHETER DYG EDWARDS LIFESCIENCES, PR 831HF75 58833458

    Patients

    Seq Age Sex Outcome Treatment
    1