BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2160856 · Received July 13, 2011

    Report

    Report Number
    3005099803-2011-02344
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 20, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A VAGINAL VAULT SUSPENSION PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, AS A LEG ASSEMBLY WAS BEING PULLED THROUGH THE PATIENT'S RIGHT SACROSPINOUS LIGAMENT, THE NEEDLE, WITH A PORTION OF SUTURE, DETACHED. THE NEEDLE, WITH A PORTION OF SUTURE, WAS REPORTEDLY CAPTURED INSIDE THE CAPIO CAGE AND DID NOT FALL LOOSE INSIDE THE PATIENT. THE PHYSICIAN TIED A STAND-ALONE CAPIO SUTURE (EXACT TYPE UNKNOWN) TO THE AFFECTED LEG AND PULLED THIS AMENDED LEG THROUGH THE LIGAMENT, COMPLETING THE PROCEDURE WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY FINE AND IS OVER 18 YEARS OF AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 ML00000106

    Patients

    Seq Age Sex Outcome Treatment
    1 CAPIO SUTURE (EXACT TYPE UNKNOWN)