BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DISPOSABLE SUTURE PLACEMENT SYSTEM

    MDR report key: 2061067 · Received April 18, 2011

    Report

    Report Number
    3005099803-2011-01243
    Event Type
    Malfunction
    Date Received
    April 18, 2011
    Date of Event
    March 21, 2011
    Report Date
    March 23, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    FHQ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN, HOWEVER, THE PATIENT WAS REPORTED TO BE (B)(6). (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF "SUTURE BROKE."

    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 POLYPROPYLENE 48-INCH SIZE 0 CAPIO SUTURE DURING A RICHTER PROCEDURE. ACCORDING TO THE COMPLAINANT, THE SUTURE WAS THROWN THROUGH THE SACROSPINOUS LIGAMENT AND RELEASED FROM THE CAPIO DEVICE, AND THE DEVICE WAS REMOVED FROM THE PATIENT. THE PHYSICIAN THEN PULLED ON BOTH ENDS OF THE SUTURE TO PERFORM THE KNOT WHEN HE OBSERVED THAT THE SUTURE HAD BROKEN INTO TWO PIECES. THE PHYSICIAN COMPLETED THE PROCEDURE WITH THE SAME CAPIO DEVICE AND ANOTHER OF THE SAME TYPE OF SUTURE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AND 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 FHQ BOSTON SCIENTIFIC - MIAMI M0068311251 13761878

    Patients

    Seq Age Sex Outcome Treatment
    1 POLYPROPYLENE 48-INCH SIZE 0 CAPIO SUTURE