BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 1912551 · Received December 2, 2010

    Report

    Report Number
    3005099803-2010-04938
    Event Type
    Malfunction
    Date Received
    December 2, 2010
    Date of Event
    November 9, 2010
    Report Date
    November 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE PATIENT'S EXACT AGE IS UNKNOWN, SHE IS REPORTED TO BE OVER 18 YEARS OF AGE. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF 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 PHYSICIAN SUCCESSFULLY PLACED THE FIRST MESH LEG ASSEMBLY INTO THE PATIENT'S SACROSPINOUS LIGAMENT. THE PHYSICIAN THEN THREW THE SECOND MESH LEG ASSEMBLY THROUGH THE PATIENT'S OTHER SACROSPINOUS LIGAMENT AND PULLED THE SUTURE THROUGH THE TISSUE. HOWEVER, THE PHYSICIAN EXPERIENCED DIFFICULTY IN REMOVING THE NEEDLE FROM THE CAPIO CAGE OUTSIDE THE PATIENT, AND THE NEEDLE, WITH 1 MILLIMETER OF SUTURE, DETACHED AND WAS CAPTURED INSIDE THE CAPIO CAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM WITHOUT ANY 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 1ML0072002

    Patients

    Seq Age Sex Outcome Treatment
    1