BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UPHOLD VAGINAL SUPPORT SYSTEM

    MDR report key: 2192704 · Received August 5, 2011

    Report

    Report Number
    3005099803-2011-02679
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 14, 2011
    Report Date
    July 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K081048
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NEITHER THE MESH ASSEMBLY NOR THE CAPIO DEVICE WERE RECEIVED FOR ANALYSIS; ONLY THE TWO LEG ASSEMBLIES WERE RETURNED. VISUAL ANALYSIS OF THE LEG ASSEMBLIES REVEALED THAT THE DILATORS AND LEADERS ON BOTH LEGS WERE BROKEN. IN ADDITION, THE SLEEVES WERE STRETCHED AND TWISTED, AND TOOL MARKS WERE OBSERVED ON BOTH DILATORS. IT WAS OBSERVED THAT BOTH TACK WELDS HAD RELEASED PROPERLY. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. THE CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A CYSTOCELE REPAIR PROCEDURE, AFTER THE LEG ASSEMBLIES OF AN UPHOLD VAGINAL SUPPORT SYSTEM WERE THROWN THROUGH THE TISSUE, THE PHYSICIAN CUT THE SLEEVES TO RELEASE THEM FROM THE MESH. AS HE WAS PULLING THE LEG ASSEMBLIES FROM THE PATIENT, EACH OF THE SLEEVES BEGAN TO SHRED AT THE CUT AREAS, AND TWO PIECES OF PLASTIC DETACHED INSIDE THE PATIENT. THE PHYSICIAN LOCATED THE PIECES OF PLASTIC THROUGH PALPATION, AND SUBSEQUENTLY REMOVED THEM WITH HIS FINGERS AND AN ALLIS CLAMP. REPORTEDLY, THE DETACHED SLEEVE PIECES FROM BOTH LEG ASSEMBLIES WERE RETRIEVED. THE PHYSICIAN FEELS THAT ALL OF THE PLASTIC WAS REMOVED FROM THE PATIENT. THE UPHOLD MESH WAS ALSO REMOVED FROM THE PATIENT, AND THE PHYSICIAN COMPLETED THE PROCEDURE BY STANDARD KELLY PLICATION, WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY FINE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A CYSTOCELE REPAIR PROCEDURE, AFTER THE LEG ASSEMBLIES OF AN UPHOLD VAGINAL SUPPORT SYSTEM WERE THROWN THROUGH THE TISSUE, THE PHYSICIAN CUT THE SLEEVES TO RELEASE THEM FROM THE MESH. AS HE WAS PULLING THE LEG ASSEMBLIES FROM THE PATIENT, EACH OF THE SLEEVES BEGAN TO SHRED AT THE CUT AREAS, AND TWO PIECES OF PLASTIC DETACHED INSIDE THE PATIENT. THE PHYSICIAN LOCATED THE PIECES OF PLASTIC THROUGH PALPATION, AND SUBSEQUENTLY REMOVED THEM WITH HIS FINGERS AND AN ALLIS CLAMP. REPORTEDLY, THE DETACHED SLEEVE PIECES FROM BOTH LEG ASSEMBLIES WERE RETRIEVED. THE PHYSICIAN FEELS THAT ALL OF THE PLASTIC WAS REMOVED FROM THE PATIENT. THE UPHOLD MESH WAS ALSO REMOVED FROM THE PATIENT, AND THE PHYSICIAN COMPLETED THE PROCEDURE BY STANDARD KELLY PLICATION, WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UPHOLD VAGINAL SUPPORT SYSTEM MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317080 1ML0120601

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention