BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUTURE PLACEMENT SYSTEM

    MDR report key: 2103134 · Received May 25, 2011

    Report

    Report Number
    3005099803-2011-01908
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    April 29, 2011
    Report Date
    April 29, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GCJ
    PMA / PMN Number
    K973415
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A CAPIO CL SUTURE CAPTURING DEVICE WAS USED WITH A CAPIO SUTURE (TYPE AND SIZE UNKNOWN) DURING A SLING FIXATION PROCEDURE. ACCORDING TO THE COMPLAINANT, THE NEEDLE OF THE SUTURE DETACHED INSIDE THE PATIENT. THE DETACHMENT OCCURRED RIGHT AT THE NEEDLE. THE PHYSICIAN ATTEMPTED TO LOCATE THE NEEDLE BUT WAS UNSUCCESSFUL AND THE NEEDLE WAS NOT REMOVED FROM THE PATIENT. NO OTHER DAMAGE WAS NOTED TO THE CAPIO DEVICE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH ANOTHER CAPIO CL DEVICE WITHOUT ANY OTHER COMPLICATIONS. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE AND THE PATIENT'S CURRENT CONDITION WERE REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ BOSTON SCIENTIFIC - MARLBOROUGH M0068311350 13484798

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Other CAPIO SUTURE (TYPE AND SIZE UNKNOWN)