BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION

    MDR report key: 1900704 · Received November 16, 2010

    Report

    Report Number
    2015691-2010-14381
    Event Type
    Malfunction
    Date Received
    November 16, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 1, 2010
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    DYG
    PMA / PMN Number
    K813521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED CATHETER REVEALED THAT THE BALLOON WAS RUPTURED DUE TO PROTRUSION OF A BROKEN LEADWIRE. FURTHER EXAMINATION FOUND THE PROXIMAL LEAD WIRE HAD BROKEN FROM THE WELD, WHICH IS LOCATED UNDER THE PROXIMAL BALLOON WINDINGS. THERE WAS NO VISIBLE DAMAGE TO THE CATHETER BODY, PROXIMAL BALLOON WINDINGS OR CATHETER TIP. THERE WERE NO SEVERE BENDS OR KINKS THAT WOULD ACCOUNT FOR PULLING OF THE LEAD WIRE FROM UNDER THE PROXIMAL WINDINGS. THE CATHETER BODY DIMENSIONS WERE MEASURED TO DETERMINE IF THE CATHETER HAD BEEN STRETCHED. ALL DIMENSIONS WERE FOUND TO BE WITHIN SPECIFICATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND IT WAS CONFIRMED THAT THE DEVICE MET SPECIFICATION UPON DISTRIBUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BALLOON DID NOT INFLATE AND COULD NOT MAINTAIN INFLATION DURING SET UP. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ BIPOLAR PACING CATHETER FOR SVC INSERTION PACING CATHETER DYG EDWARDS LIFESCIENCES, PR PE074F5 58860185

    Patients

    Seq Age Sex Outcome Treatment
    1