BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2103150 · Received May 25, 2011

    Report

    Report Number
    3005099803-2011-01832
    Event Type
    Malfunction
    Date Received
    May 25, 2011
    Date of Event
    May 4, 2011
    Report Date
    May 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO THE SECOND OF TWO DEVICES USED DURING THE SAME PROCEDURE. ASSOCIATED MANUFACTURER REPORT #3005099803-2011-01787 PERTAINS TO THE FIRST DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A UTERINE PROLAPSE REPAIR PROCEDURE USING AN UPHOLD VAGINAL SUPPORT SYSTEM, THE FIRST LEG ASSEMBLY WAS SUCCESSFULLY PLACED THROUGH A SACROSPINOUS LIGAMENT. THE SECOND LEG ASSEMBLY WAS THEN PULLED THROUGH THE OTHER SACROSPINOUS LIGAMENT, AND THE PHYSICIAN REMOVED THE SUTURE BULLET FROM THE CAPIO CAGE AND USED A HEMOSTAT ON THE SUTURE TO CONTINUE PULLING THE LEG ASSEMBLY. AS HE WAS DOING SO, ABOUT ONE HALF-INCH OF THE SUTURE, WITH THE NEEDLE AT THE END, DETACHED FROM THE LEG ASSEMBLY. THE SUTURE PIECE WITH THE NEEDLE DID NOT FALL LOOSE INTO THE PATIENT, AND WAS REMOVED ALONG WITH THE HEMOSTAT. AS THE PHYSICIAN NEXT PULLED THE LEG ASSEMBLY WITH THE HEMOSTAT ON THE REMAINING PORTION OF SUTURE, ANOTHER PORTION OF THE SUTURE DETACHED. THIS SUTURE PIECE DID NOT FALL LOOSE INTO THE PATIENT, AND WAS REMOVED ALONG WITH THE HEMOSTAT. THE PHYSICIAN THEN CUT OFF THE SECOND LEG ASSEMBLY FROM THIS DEVICE AND THE INTACT LEG ASSEMBLY FROM THE FIRST UPHOLD DEVICE. HE SUTURED THE FREED LEG ASSEMBLY FROM THE FIRST DEVICE TO THE IMPLANTED MESH BODY OF THE SECOND DEVICE. THE AMENDED LEG ASSEMBLY WAS SUCCESSFULLY PLACED THROUGH THE LIGAMENT, AND THE PHYSICIAN COMPLETED THE PROCEDURE WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY FINE, AND IS OVER 18 YEARS OF AGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 1ML1022205

    Patients

    Seq Age Sex Outcome Treatment
    1 UPHOLD VAGINAL SUPPORT SYSTEM