BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 1840417 · Received September 21, 2010

    Report

    Report Number
    3005099803-2010-03971
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 31, 2010
    Report Date
    August 31, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS IMPLANTED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A POSTERIOR PELVIC FLOOR REPAIR PROCEDURE USING A PINNACLE POSTERIOR PFR KIT, AS THE PHYSICIAN WAS ATTEMPTING TO THROW THE MESH LEG THROUGH THE SACROSPINOUS LIGAMENT, AN INCH OF SUTURE (WITH THE NEEDLE AT THE END) DETACHED FROM IT AND WAS CAPTURED IN THE CAPIO DEVICE. THE PHYSICIAN TIED A STANDALONE CAPIO SUTURE TO THE AFFECTED MESH LEG AND WAS ABLE TO COMPLETE THE PROCEDURE, WITHOUT COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317100 1ML0051212

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR