BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 1920197 · Received December 10, 2010

    Report

    Report Number
    3005099803-2010-05100
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 5, 2010
    Report Date
    November 16, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EXPIRATION DATE: THOUGH THE LOT# OF THE DEVICE IS UNKNOWN, THE COMPLAINANT INDICATED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRATION DATE. (B)(4) - REMOVAL OF FOREIGN BODY. (B)(4) - THE REPORTED ISSUE OF NEEDLE DETACHMENT. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE OF 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 CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE, THE PHYSICIAN ATTEMPTED TO IMPLANT A REPLIFORM GRAFT (MANUFACTURED BY LIFECELL CORP, DISTRIBUTED BY BOSTON SCIENTIFIC CORP.) WITH A CAPIO SUTURE (MANUFACTURED BY TELEFLEX MEDICAL INC, DISTRIBUTED BY BOSTON SCIENTIFIC CORP.), WHEN THE NEEDLE OF THE CAPIO SUTURE DETACHED INSIDE THE PATIENT AS THE SUTURE WAS THROWN INTO THE PATIENT'S ARCUS TENDINEUS. THE NEEDLE BECAME LODGED WITHIN THE PATIENT'S TISSUE. THE PHYSICIAN THEN LOCATED AND RETRIEVED THE NEEDLE FROM INSIDE THE PATIENT UNDER FLUOROSCOPY, WHICH REPORTEDLY DELAYED THE PROCEDURE BY AN HOUR. ANOTHER CAPIO SUTURE WAS THEN USED TO IMPLANT THE REPLIFORM GRAFT SUCCESSFULLY. IT IS UNKNOWN WHETHER OR NOT THE SAME CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE WAS USED. POST-PROCEDURE, THE PATIENT REPORTEDLY PRESENTED WITH "SEVERE" PELVIC PAIN THAT LASTED FOR "A COUPLE OF DAYS," WHICH THE PHYSICIAN ATTRIBUTED TO "THE LENGTHY PROCESS OF EXTRACTING THE CAPIO SUTURE NEEDLE FROM THE PATIENT." IT IS UNKNOWN WHAT INTERVENTION, IF ANY, WAS PERFORMED BY THE PHYSICIAN TO TREAT THE PAIN. WHILE THE PATIENT HAS PELVIC SORENESS, SHE IS REPORTED TO BE "DOING WELL." ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY FHQ BOSTON SCIENTIFIC - COSTA RICA M0068311251

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention REPLIFORM GRAFT (LIFECELL CORP.)| CAPIO SUTURE (TELEFLEX MEDICAL INC.)