BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 1803983 · Received August 17, 2010

    Report

    Report Number
    3005099803-2010-03531
    Event Type
    Injury
    Date Received
    August 17, 2010
    Date of Event
    July 23, 2010
    Report Date
    July 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    GCJ
    PMA / PMN Number
    K932553
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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. (B)(6). (B)(4) THE REPORTED EVENT OF NEEDLE DETACHMENT. DEVICE CODE 3191: NO CODE AVAILABLE FOR FAILURE TO CATCH.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT DURING A VAGINAL VAULT SUSPENSION PROCEDURE USING A CAPIO DEVICE (TYPE UNKNOWN) AND A BONDEK SUTURE (MANUFACTURED BY TELEFLEX MEDICAL INC.; (B)(4)WHEN THE PHYSICIAN FIRST ATTEMPTED TO SUTURE THE PATIENT'S VAGINAL VAULT TO THE SACROSPINOUS LIGAMENT, THE SUTURE NEEDLE PASSED THROUGH THE SACROSPINOUS LIGAMENT SUCCESSFULLY, BUT WAS NOT CAPTURED INSIDE THE CAPIO CAGE. DURING THE PHYSICIAN'S SECOND ATTEMPT TO SUTURE THE PATIENT'S VAGINAL VAULT TO THE SACROSPINOUS LIGAMENT, THE SUTURE NEEDLE DETACHED INSIDE THE PATIENT. THE PHYSICIAN THEN ATTEMPTED TO SUTURE THE VAGINAL VAULT TO THE SACROSPINOUS LIGAMENT USING THE NEEDLE ATTACHED TO THE OTHER END OF THE BONDEK SUTURE, BUT THAT NEEDLE DETACHED INSIDE THE PATIENT AS WELL. THE PHYSICIAN PERFORMED AN X-RAY TO TRY AND LOCATE THE NEEDLES, BUT WAS REPORTEDLY UNABLE TO DO SO DUE TO THE "LIMITED AREA OF EXPOSURE," AND BECAUSE THE NEEDLES WERE "TOO SMALL TO BE SEEN ON AN X-RAY." THE PHYSICIAN BELIEVES THE NEEDLES REMAIN INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING ANOTHER CAPIO DEVICE AND ANOTHER BONDEK SUTURE. REPORTEDLY, "NO ADVERSE EFFECTS" TO THE PATIENT WERE NOTED POST-PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ BOSTON SCIENTIFIC - MIAMI UNK55

    Patients

    Seq Age Sex Outcome Treatment
    1 Other BONDEK SUTURE (MANUFACTURER: TELEFLEX MEDICAL INC)