BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 1840444 · Received September 21, 2010

    Report

    Report Number
    3005099803-2010-04035
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    August 30, 2010
    Report Date
    August 30, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED 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 AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE FIRST LEG WAS IMPLANTED INTO THE SACROSPINOUS LIGAMENT SUCCESSFULLY. THE PHYSICIAN THREW THE SECOND LEG THROUGH THE LIGAMENT, BUT WAS UNHAPPY WITH THE PLACEMENT WITHIN THE LIGAMENT. AS THE PHYSICIAN ATTEMPTED TO RETHROW THE LEG, THE NEEDLE DETACHED AND WAS CAPTURED INSIDE THE CAPIO DEVICE.THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT. BECAUSE A SECOND UPHOLD VAGINAL SUPPORT SYSTEM WAS NOT AVAILABLE, THE PHYSICIAN USED A PINNACLE ANTERIOR/APICAL PFR KIT AND MODIFIED IT'S MESH ASSEMBLY BY REMOVING THE TWO ARCUS TENDINEOUS LEGS 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 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 1ML0051701

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR