BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2936271 · Received January 30, 2013

    Report

    Report Number
    3005099803-2013-00516
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    October 10, 2012
    Report Date
    October 10, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. VISUAL ANALYSIS OF THE RETURNED MESH ASSEMBLY REVEALED NO ANOMALIES. VISUAL ANALYSIS OF THE RETURNED CAPIO DEVICE REVEALED THAT THE CAGE WAS BENT. FUNCTIONAL TESTING OF THE RETURNED CAPIO DEVICE SHOWED THAT IT THE CARRIER HAD RESISTANCE WHEN ACTUATED, AND WOULD NOT RETRACT COMPLETELY UNLESS FORCE WAS APPLIED ON THE PLUNGER. THE ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR VAULT REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE CAPIO CAGE WOULD NOT CAPTURE THE LEAD SUTURE. REPORTEDLY, THIS OCCURRED ON THE FIRST FIRING OF THE CAPIO DEVICE. IN ADDITION, THE CAGE WAS OBSERVED TO BE BENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO COMPLICATIONS TO THE PATIENT, WHO WAS STABLE AT THE CONCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40344 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 ML00000600

    Patients

    Seq Age Sex Outcome Treatment
    1