BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 1822986 · Received September 1, 2010

    Report

    Report Number
    3005099803-2010-03651
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    July 23, 2010
    Report Date
    August 10, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL ANALYSIS OF THE RETURNED UPHOLD MESH SHOWED THAT THE SUTURE, WITH THE NEEDLE AT THE END, HAD DETACHED FROM THE END OF THE BLUE AND WHITE DILATOR. THE COMPLAINT WAS CONFIRMED. THE HANDLE OF THE RETURNED CAPIO DEVICE WAS ALSO OBSERVED TO BE CRACKED. MECHANICAL ANALYSIS OF THE CAPIO DEVICE FOUND THAT THE DEVICE OPERATED FREELY AND SMOOTHLY. THE PROBABLE CAUSE OF THE SUTURE DETACHMENT WAS DETERMINED TO BE OPERATIONAL CONTEXT. THE PROBABLE CAUSE OF THE CRACKED HANDLE ON THE CAPIO DEVICE WAS DETERMINED TO BE SHIPPING DAMAGE DURING TRANSIT TO BOSTON SCIENTIFIC.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. 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 A PELVIC FLOOR REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE NEEDLE WITH "A LITTLE SUTURE LEFT ON IT" DETACHED FROM THE MESH LEG AS THE PHYSICIAN WAS PULLING IT THROUGH THE SACROSPINOUS LIGAMENT, WITH THE CAPIO DEVICE. THE SUTURE (WITH THE NEEDLE AT THE END) DID NOT FALL INSIDE THE PATIENT. THE PHYSICIAN USED ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM TO COMPLETE THE PROCEDURE WITHOUT COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A PELVIC FLOOR REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE NEEDLE WITH "A LITTLE SUTURE LEFT ON IT" DETACHED FROM THE MESH LEG AS THE PHYSICIAN WAS PULLING IT THROUGH THE SACROSPINOUS LIGAMENT, WITH THE CAPIO DEVICE. THE SUTURE (WITH THE NEEDLE AT THE END) DID NOT FALL INSIDE THE PATIENT. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR