BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 2193545 · Received August 5, 2011

    Report

    Report Number
    3005099803-2011-02540
    Event Type
    Injury
    Date Received
    August 5, 2011
    Date of Event
    July 4, 2011
    Report Date
    July 12, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    GCJ
    PMA / PMN Number
    K932553
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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 OPEN ACCESS SUTURE CAPTURING DEVICE WAS USED WITH A CAPIO BONDEK PGA ABSORBABLE SUTURE DURING A VAGINAL PROLAPSE REPAIR PROCEDURE. ACCORDING TO THE COMPLAINANT, AFTER THE PHYSICIAN THREW A SUTURE THROUGH THE SACROSPINOUS LIGAMENT AND PULLED OUT THE DEVICE, HE NOTICED THAT THE END OF THE SUTURE DID NOT COME OUT WITH THE CAPIO HEAD. IT IS UNKNOWN WHETHER THE SUTURE FAILED TO CATCH INSIDE THE CAPIO CAGE OR IF THE CAGE FAILED TO RETAIN THE NEEDLE WHEN THE SUTURE WAS THROWN. THE PHYSICIAN THEN WENT BACK INTO THE INCISION AND RETRIEVED THE SUTURE BY HAND BUT FOUND THAT THE NEEDLE HAD SEPARATED FROM THE SUTURE. THE PHYSICIAN ATTEMPTED TO LOCATE THE NEEDLE VIA PALPATION BUT WAS UNSUCCESSFUL. THE NEEDLE WAS NOT RETRIEVED FROM THE PATIENT. IT WAS REPORTED THAT HEMOSTATS WERE NOT USED TO GRAB THE SUTURE. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THIS CAPIO DEVICE AND ANOTHER SUTURE WITH NO OTHER PATIENT COMPLICATIONS. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DISPOSABLE SUTURE PLACEMENT SYSTEM LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ BOSTON SCIENTIFIC - MIAMI M0068311250

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention CAPIO BONDEK PGA ABSORBABLE SUTURE