BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 1982380 · Received February 9, 2011

    Report

    Report Number
    3005099803-2011-00257
    Event Type
    Malfunction
    Date Received
    February 9, 2011
    Date of Event
    January 20, 2011
    Report Date
    January 20, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: VISUAL ANALYSIS OF THE RETURNED MESH ASSEMBLY REVEALED THAT A PORTION OF THE LEAD SUTURE WITH THE NEEDLE AT THE END WAS MISSING FROM THE SOLID BLUE MESH LEG ASSEMBLY, INDICATING THAT THE LEAD SUTURE FAILED AND BROKE IN THE PROXIMITY OF THE NEEDLE. VISUAL ANALYSIS OF THE RETURNED CAPIO DEVICE REVEALED NO DEFECTS OR DAMAGE. FUNCTIONAL ANALYSIS OF THE RETURNED CAPIO DEVICE SHOWED THAT IT OPERATED FREELY AND SMOOTHLY. THE REPORTED MISFIRING COULD NOT BE CONFIRMED. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. THE DIRECTIONS FOR USE FOR THE DEVICE INCLUDES THE FOLLOWING PRECAUTION STATEMENT: "AVOID EXCESSIVE TENSION ON THE MESH DURING HANDLING AND POSITIONING TO PREVENT DAMAGE TO THE DEVICE." THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS DETERMINED TO BE OPERATIONAL CONTEXT.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN "ANTERIOR/POSTERIOR REPAIR" PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE NEEDLE "MISFIRED" AND DETACHED. REPORTEDLY, THE NEEDLE DID NOT FALL LOOSE INSIDE THE PATIENT, AND INSTEAD "FELL OFF ONTO THE FLOOR." THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN "ANTERIOR/POSTERIOR REPAIR" PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE NEEDLE "MISFIRED" AND DETACHED. REPORTEDLY, THE NEEDLE DID NOT FALL LOOSE INSIDE THE PATIENT, AND INSTEAD "FELL OFF ONTO THE FLOOR." THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER UPHOLD VAGINAL SUPPORT SYSTEM WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 1ML0070603

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR