BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 1791988 · Received August 10, 2010

    Report

    Report Number
    3005099803-2010-03487
    Event Type
    Malfunction
    Date Received
    August 10, 2010
    Date of Event
    May 12, 2010
    Report Date
    May 12, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL MANUFACTURER NARRATIVE:(B)(4) FOR THE INVESTIGATIONAL RESULTS OF CARRIER FAILING TO RETRACT AND BEING BENT. DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED CAPIO DEVICE SHOWED THAT THE CARRIER WAS BENT AND STUCK IN THE OPEN POSITION. MECHANICAL ANALYSIS OF THE RETURNED CAPIO DEVICE FOUND THAT THE CARRIER WAS UNABLE TO RETRACT AND CLOSE. THE PROBABLE CAUSE FOR THIS EVENT WAS UNABLE TO BE DETERMINED.

    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 NEEDLE WOULD NOT CATCH INSIDE THE CAPIO CAGE WHEN THE PHYSICIAN ATTEMPTED SEVERAL TIMES TO THROW THE FIRST MESH LEG THROUGH THE SACROSPINOUS LIGAMENT. NO VISIBLE DAMAGE TO THE CAPIO DEVICE WAS NOTED. THE PHYSICIAN 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 1ML0022201

    Patients

    Seq Age Sex Outcome Treatment
    1