BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION

    MDR report key: 3243628 · Received July 23, 2013

    Report

    Report Number
    2015691-2013-20657
    Event Type
    Malfunction
    Date Received
    July 23, 2013
    Date of Event
    June 26, 2013
    Report Date
    June 26, 2013
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    LDF
    PMA / PMN Number
    K813521
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONE BIPOLAR PACING CATHETER WAS RECEIVED WITH A MONOJECT 1.3CC LIMITED SYRINGE. CONTINUITY TESTING REVEALED THAT THE DISTAL LEADWIRE HAD AN INTERMITTENT CONDITION AROUND THE ELECTRODE, WHEN FLEXING THE TIP AREA OF THE CATHETER. THE PROXIMAL CIRCUIT WAS CONTINUOUS WITHOUT ANY INTERMITTENT OR OPEN CONDITION. THERE WERE NO SHORT CONDITION OBSERVED BETWEEN THE PROXIMAL AND DISTAL LEADWIRES. THE BALLOON INFLATED CLEARLY AND AND CONCENTRICALLY AND REMAINED INFLATED FOR 5 MINUTES WITHOUT LEAKAGE OBSERVED. THE CATHETER TIP UNDER THE BALLOON APPEARED BENT. THERE WAS NO VISIBLE DAMAGE OBSERVED FROM THE WINDINGS, THE BALLOON, OR THE RETURNED SYRINGE. A REVIEW OF THE MANUFACTURING RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS UPON RELEASE. CUSTOMER REPORT OF PACING ISSUE WAS CONFIRMED. AN INVESTIGATION WAS OPENED TO DETERMINE THE CAUSE OF THE COMPLAINT AND IMPLEMENT ANY NECESSARY ACTIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT "IT WAS UNABLE TO PACE DURING USE." THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343211 SWAN-GANZ BIPOLAR PACING CATHETER FOR FEMORAL INSERTION ELECTRODE, PACEMAKER, TEMPORARY LDF EDWARDS LIFESCIENCES, PR PE075F5 59446329

    Patients

    Seq Age Sex Outcome Treatment
    1