BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 1823026 · Received September 1, 2010

    Report

    Report Number
    3005099803-2010-03658
    Event Type
    Malfunction
    Date Received
    September 1, 2010
    Date of Event
    August 11, 2010
    Report Date
    August 11, 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

    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 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. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND NO ISSUES THAT COULD HAVE CONTRIBUTED TO THIS EVENT WERE FOUND. 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.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S WEIGHT IS ESTIMATED TO BE (B)(6). 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 APICAL PELVIC FLOOR REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, APPROXIMATELY TWO MILLIMETERS OF LEAD SUTURE (WITH THE NEEDLE AT THE END) DETACHED FROM THE FIRST MESH LEG AS THE PHYSICIAN WAS ATTEMPTING TO PLACE IT IN THE PATIENT'S SACROSPINOUS LIGAMENT. IT IS UNCLEAR IF THE LEAD SUTURE WAS WITHIN THE SACROSPINOUS LIGAMENT WHEN THE BREAK OCCURRED. THE LEAD SUTURE (WITH THE NEEDLE AT THE END) WAS CAPTURED INSIDE THE CAPIO DEVICE. 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 AN ANTERIOR APICAL PELVIC FLOOR REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, APPROXIMATELY TWO MILLIMETERS OF LEAD SUTURE (WITH THE NEEDLE AT THE END) DETACHED FROM THE FIRST MESH LEG AS THE PHYSICIAN WAS ATTEMPTING TO PLACE IT IN THE PATIENT'S SACROSPINOUS LIGAMENT. IT IS UNCLEAR IF THE LEAD SUTURE WAS WITHIN THE SACROSPINOUS LIGAMENT WHEN THE BREAK OCCURRED. THE LEAD SUTURE (WITH THE NEEDLE AT THE END) WAS CAPTURED INSIDE THE CAPIO DEVICE. 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 1ML0010606

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR