BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 1744025 · Received July 1, 2010

    Report

    Report Number
    3005099803-2010-02924
    Event Type
    Injury
    Date Received
    July 1, 2010
    Date of Event
    June 7, 2010
    Report Date
    June 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    MFJ
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4) MEDICATIONS, FAILED TO CATCH OR FAILED TO LOAD. 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 REPAIR PROCEDURE TO TREAT A GRADE 3 CYSTOCELE USING A CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE, THE NEEDLES ATTACHED TO THREE SIZE 0 CAPIO SUTURES (MANUFACTURED BY TELEFLEX MEDICAL INC, DISTRIBUTED BY BOSTON SCIENTIFIC CORPORATION) "COULD NOT LOCK AFTER THE STRING PASSAGE" AND "SEPARATED FROM THE STRING" DURING THE REMOVAL OF THE CAPIO DEVICE FROM THE PATIENT'S RIGHT ARCHUS TENDINEUS. THE NEEDLES WERE REPORTEDLY NOT LOST INSIDE THE PATIENT, AND "CAME OUT WITH THE (CAPIO) DEVICE." AN X-RAY WAS PERFORMED BY THE PHYSICIAN, PRESUMABLY TO CONFIRM THAT NO NEEDLES WERE LOST INSIDE THE PATIENT. ADDITIONALLY, THE PATIENT WAS PRESCRIBED SPINAL ANALGESIA MEDICATIONS, BUT FOLLOW-UP ATTEMPTS TO ASCERTAIN WHY PROVED UNSUCCESSFUL. IT WAS ALSO REPORTED THAT THE CAPIO CAGE WOULD NOT CATCH THE NEEDLES AND THAT THE SUTURES WOULD NOT STAY WITHIN THE CAPIO CARRIER. THE PROCEDURE WAS COMPLETED THE "TRADITIONAL," "OLD CLASSIC WAY," WITHOUT THE USE OF ANY OTHER CAPIO DEVICE AND THE PATIENT IS REPORTED TO BE "STABLE" POST-PROCEDURE. FOLLOW-UP ATTEMPTS TO ASCERTAIN HOW EXACTLY THE PROCEDURE WAS COMPLETED HAVE PROVED UNSUCCESSFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY MFJ BOSTON SCIENTIFIC - MIAMI M0068311251 12369368

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention CAPIO SUTURES (MANUFACTURER: TELEFLEX MEDICAL INC)