BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION

    MDR report key: 2883526 · Received December 21, 2012

    Report

    Report Number
    2015691-2012-18920
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    LDF
    PMA / PMN Number
    K813521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE BIPOLAR PACING CATHETER WITH ATTACHED MONOJECT 1.3 CC LIMITED VOLUME SYRINGE WAS RETURNED FOR EVALUATION. NO INTRODUCER WAS RETURNED. CONTINUITY TESTING FOUND THAT A SHORT CONDITION OCCURRED AT THE CATHETER TIP. A CUT-DOWN OF THE CATHETER REVEALED THAT THE INSULATION ON THE LEAD WIRE HAD BEEN STRIPPED TOO FAR, WHICH CREATED A SHORT CONDITION WHEN PACING. THE BALLOON INFLATED CLEAR AND CONCENTRIC AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE. BALLOON INFLATION TESTING WAS PERFORMED USING THE RETURNED SYRINGE WITH 1.3 CC AIR BY HOLDING THE BALLOON UNDER WATER. NO VISIBLE DAMAGE TO THE CATHETER BODY, BALLOON, BALLOON WINDINGS, OR RETURNED SYRINGE WAS OBSERVED. VISUAL EXAMINATION WAS PERFORMED UNDER MICROSCOPE AT 20X MAGNIFICATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT THE DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. THE CUSTOMER REPORT OF PACING DIFFICULTY WAS CONFIRMED DURING THE EVALUATION. AN INVESTIGATION HAS BEEN INITIATED TO DETERMINE THE ROOT CAUSE AND IMPLEMENT ANY NECESSARY CORRECTIVE ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IT WAS UNABLE TO PACE DURING USE." NO PATIENT COMPLICATIONS OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION LDF EDWARDS LIFESCIENCES, PR PE075F5

    Patients

    Seq Age Sex Outcome Treatment
    1