BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 1830311 · Received September 10, 2010

    Report

    Report Number
    3005099803-2010-03795
    Event Type
    Malfunction
    Date Received
    September 10, 2010
    Date of Event
    August 18, 2010
    Report Date
    August 18, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR EVALUATION. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR 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 MESH LEG WAS PLACED SUCCESSFULLY ON THE PATIENT'S LEFT SIDE. AS THE PHYSICIAN THREW THE SECOND LEG IN THE PATIENT'S RIGHT SIDE INTO THE SACROSPINOUS LIGAMENT AND ATTEMPTED TO PULL IT THROUGH WITH THE CAPIO DEVICE, RESISTANCE WAS ENCOUNTERED. BECAUSE OF THIS TENSION, "A SMALL AMOUNT" OF SUTURE (WITH THE NEEDLE AT THE END) DETACHED AND WAS CAPTURED INSIDE THE CAPIO DEVICE. THE PHYSICIAN REMOVED THE ENTIRE UPHOLD MESH ASSEMBLY FROM THE PATIENT AND USED ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM 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 0ML9101401

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR