BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KIT

    MDR report key: 1211332 · Received October 22, 2008

    Report

    Report Number
    3005099803-2008-05437
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 25, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    FTM
    PMA / PMN Number
    K071957
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED, BUT AN EVALUATION HAS NOT YET BEEN PERFORMED. THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE, AND THE CAUSE FOR THIS EVENT.

    Description of Event or Problem · 1

    A PINNACLE PELVIC FLOOR REPAIR KIT WAS USED DURING AN ANTERIOR FLOOR REPAIR PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE CLINICIANS HAD COMPLETED THE DISSECTION AND WERE AT THE POINT OF PASSING THE FIRST SACROSPINOUS ARM, WHEN THE SUTURE BROKE BETWEEN THE BULLET AND THE SHEATH. NO PARTS FELL IN THE PT. IT WAS THE FIRST ARM; FIRST THROW WHEN THE SACROSPINOUS ARM BROKE. WHEN THE DEVICE WAS REMOVED, IT WAS NOTICED THAT THE ARM ASSEMBLY ON THE TIP OF THE SUTURE HAD COILED. THE BROKEN PART OF THE SUTURE LOOKED LIKE IT HAD A STRAIGHT CUT. THE CLINICIANS REPORTED THAT THIS WAS NOT DONE UNDER EXCESSIVE TENSION. THE CLINICIANS THEN OBTAINED ANOTHER DEVICE AND COMPLETED THIS PT PROCEDURE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PT'S CONDITION WAS REPORTED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KIT FTM BOSTON SCIENTIFIC CORPORATION M0068317050 OML80722901

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR