BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2781427 · Received October 10, 2012

    Report

    Report Number
    3005099803-2012-04596
    Event Type
    Malfunction
    Date Received
    October 10, 2012
    Date of Event
    September 17, 2012
    Report Date
    September 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. THE MESH ASSEMBLY WAS NOT RECEIVED FOR ANALYSIS. VISUAL ANALYSIS OF THE RETURNED CAPIO DEVICE REVEALED THAT THE NEEDLE CARRIER WAS STUCK IN THE FULLY DEPLOYED/OPEN POSITION IN ADDITION, BOTH THE CARRIER AND CAGE WERE BENT. FUNCTIONAL TESTING OF THE RETURNED CAPIO DEVICE REVEALED THAT THE CARRIER WOULD NOT RETRACT FULLY. IN ADDITION, THE PLUNGER WAS ABLE TO BE DEPLOYED, WITH NO EFFECT ON THE CARRIER. FURTHER ENGINEERING ANALYSIS REVEALED THAT THE CARRIER WOULD NOT RETRACT BECAUSE IT HAD TRAVELED TOO FAR FORWARD AND ITS COMPONENT PARTS HAD SEPARATED FOR ENOUGH SO THAT IT WAS UNABLE TO RETRACT INTO THE CAPIO DEVICE. THE SHAFT WHICH DRIVES THE CARRIER HAD SEPARATED AT A POINT AT WHICH TWO SECTIONS ARE CRIMPED TOGETHER. NO DEFECTS WERE OBSERVED ON THE DISASSEMBLED DEVICE WHICH WOULD INDICATE A MANUFACTURING CAUSE; THEREFORE, THE DEVICE MET SPECIFICATION BUT DUE TO ANATOMICAL/PROCEDURAL FACTORS ITS PERFORMANCE WAS LIMITED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN UPHOLD VAGINAL SUPPORT SYSTEM WAS USED DURING A PELVIC FLOOR REPAIR PROCEDURE. AFTER THE PHYSICIAN COMPLETED PLACEMENT OF THE FIRST SIDE, THE NEEDLE CARRIER FAILED TO RETRACT COMPLETELY. THE PHYSICIAN WAS UNABLE TO LOAD THE NEXT LEG ASSEMBLY INTO THE CAPIO DEVICE BECAUSE OF THIS. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER CAPIO SUTURE CAPTURING DEVICE WITH NO COMPLICATIONS OR HARM TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE CAPIO NEEDLE CARRIER HAD FAILED TO FULLY RETRACT AS THE CAPIO DEVICE WAS BEING LOADED, OUTSIDE THE PATIENT. THERE WAS NO EXCESSIVE TISSUE, AND NO NOTICEABLE DAMAGE TO ANY PART OF THE CAPIO DEVICE. ALTHOUGH THE LOT NUMBER WAS NOT PROVIDED, IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1