BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE PELVIC FLOOR REPAIR KITS

    MDR report key: 1951232 · Received January 6, 2011

    Report

    Report Number
    3005099803-2010-05306
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 14, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    FTL
    PMA / PMN Number
    K071957
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION: VISUAL EVALUATION OF THE RETURNED MESH LEG ASSEMBLIES REVEALED THAT TWO OF THE LEAD SUTURES WITH NEEDLES WERE DETACHED FROM THEIR DILATORS. IN ADDITION, THE REMAINING TWO LEAD SUTURES WERE MISSING FROM THEIR DILATORS AND WERE NOT RETURNED. NEITHER THE MESH BODY ASSEMBLY NOR THE CAPIO DEVICE WERE RETURNED FOR EVALUATION. 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

    'PATIENT AGE/DATE OF BIRTH' WHILE THE EXACT PATIENT AGE OR DATE OF BIRTH IS UNKNOWN, THE PATIENT IS REPORTEDLY OVER 18 YEARS OF AGE. (B)(4) - NEEDLE DETACHMENT. THE COMPLAINANT INDICATED THAT THE DEVICE WILL BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED. 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE USING A PINNACLE PELVIC FLOOR REPAIR KIT, AS THE PHYSICIAN WAS PULLING THE SECOND MESH LEG ASSEMBLY THROUGH THE ARCUS TENDINEUS LIGAMENT, A "NORMAL" AMOUNT OF RESISTANCE WAS ENCOUNTERED AND HE NOTICED THAT "THE BULLET FROM THE END OF THE SUTURE WAS MISSING." REPORTEDLY, THE DETACHMENT OCCURRED "RIGHT AT THE NEEDLE" AND "NO SUTURE WAS LEFT BEHIND." THE PHYSICIAN INDICATED THAT HE WAS UNABLE TO FIND THE NEEDLE, AND DECIDED NOT TO SEARCH FOR THE NEEDLE BECAUSE "HE FEARED HE WOULD HAVE CAUSED INJURY TO THE PATIENT". ADDITIONALLY, THE PHYSICIAN NOTED THAT "AS FAR AS HE KNOWS [THE NEEDLE] IS STILL IN THE PATIENT." IT WAS REPORTED THAT AS THE PHYSICIAN WAS REMOVING THE MESH LEG ASSEMBLY, A PORTION OF THE SLEEVE FROM THE MESH LEG ASSEMBLY "BROKE OFF IN THE PATIENT" AND WAS SUBSEQUENTLY REMOVED BY HIS HAND. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THIS DEVICE WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING AN ANTERIOR PELVIC FLOOR REPAIR PROCEDURE USING A PINNACLE PELVIC FLOOR REPAIR KIT, AS THE PHYSICIAN WAS PULLING THE SECOND MESH LEG ASSEMBLY THROUGH THE ARCUS TENDINEUS LIGAMENT, A "NORMAL" AMOUNT OF RESISTANCE WAS ENCOUNTERED AND HE NOTICED THAT "THE BULLET FROM THE END OF THE SUTURE WAS MISSING." REPORTEDLY, THE DETACHMENT OCCURED "RIGHT AT THE NEEDLE" AND "NO SUTURE WAS LEFT BEHIND." THE PHYSICIAN INDICATED THAT HE WAS UNABLE TO FIND THE NEEDLE, AND DECIDED NOT TO SEARCH FOR THE NEEDLE BECAUSE "HE FEARED HE WOULD HAVE CAUSED INJURY TO THE PATIENT". ADDITIONALLY, THE PHYSICIAN NOTED THAT "AS FAR AS HE KNOWS [THE NEEDLE] IS STILL IN THE PATIENT." IT WAS REPORTED THAT AS THE PHYSICIAN WAS REMOVING THE MESH LEG ASSEMBLY, A PORTION OF THE SLEEVE FROM THE MESH LEG ASSEMBLY "BROKE OFF IN THE PATIENT" AND WAS SUBSEQUENTLY REMOVED BY HIS HAND. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THIS DEVICE WITH NO COMPLICATIONS TO THE PATIENT, WHO IS REPORTEDLY "FINE" POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE PELVIC FLOOR REPAIR KITS MESH, SURGICAL, POLYMERIC FTL BOSTON SCIENTIFIC - MARLBOROUGH M0068317050 1ML0070801

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention