BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 2221056 · Received August 23, 2011

    Report

    Report Number
    3005099803-2011-02849
    Event Type
    Injury
    Date Received
    August 23, 2011
    Date of Event
    August 3, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE PATIENT WAS IMPLANTED WITH A PINNACLE POSTERIOR PELVIC FLOOR REPAIR KIT DURING A POSTERIOR REPAIR PROCEDURE. AFTER THE MESH WAS FULLY PLACED AND BEFORE THE PATIENT WAS CLOSED, THE PHYSICIAN PERFORMED A RECTAL EXAM AND FELT A SMALL HOLE THROUGH THE RECTUM INTO THE PERINEAL BODY. THE PHYSICIAN NOTED THAT THERE WERE NO PATIENT ANATOMICAL ABNORMALITIES THAT COULD HAVE CONTRIBUTED TO THIS EVENT, AND THAT THE HOLE WAS LIKELY MADE DURING HER INITIAL DISSECTION INCISION NEAR THE PERINEAL BODY. THE PHYSICIAN ALSO NOTED DURING THE RECTAL EXAM THAT SHE MAY HAVE FELT THE MESH, AND SHE TRIMMED THE TAIL SLIGHTLY. THERE WAS UNDER 100CC'S OF BLOOD LOSS, WHICH WAS "NEVER AN ISSUE." THE PHYSICIAN REPAIRED THE HOLE WITH SOME VICRYL AND SILK SUTURES ON THE DISTAL PORTION OF THE RECTUM. SHE REMOVED THE PINNACLE MESH FROM THE PATIENT AND COMPLETED THE PROCEDURE WITHOUT ANY MESH BY A BASIC PLICATION REPAIR WITH NO FURTHER COMPLICATIONS TO THE PATIENT, WHO WAS REPORTEDLY FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317100 1ML1020302

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention VICRYL SUTURES| SILK SUTURES (MANUFACTURER UNKNOWN)