BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE

    MDR report key: 1054526 · Received May 29, 2008

    Report

    Report Number
    3005099803-2008-00568
    Event Type
    Malfunction
    Date Received
    May 29, 2008
    Date of Event
    April 29, 2008
    Report Date
    April 29, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MFJ
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED TO BOSTON SCIENTIFIC CORP THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. A DHR REVIEW WAS CONDUCTED; THERE WERE NO ISSUES NOTED RELATED TO THIS COMPLAINT. A LOT HISTORY SEARCH WAS PERFORMED; THERE WERE NO OTHER COMPLAINTS FOR THE REPORTED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORP THAT WHILE PERFORMING A SACROCOLPOPLEXY, USING AN OPC-CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE, AND WHILE PULLING THE SUTURE OUT, THE PHYSICIAN COULD NOT FIND THE NEEDLE/DART. THE CAPIO DEVICE WAS CHECKED AND IT WAS REPORTED THAT THEY WERE UNCERTAIN IF THE PIECE "REMAINED WITHIN THE PT OR SOMEHOW ENDED UP ON THE FLOOR." THE PHYSICIAN REPORTED THAT THE PIECE IS SO SMALL THAT IF IT DID REMAIN WITHIN THE PT THERE IS NO EXPECTATION OF ANY PROBLEM. THE PROCEDURE WAS COMPLETED WITH NO REPORTED COMPLICATIONS FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CAPIO OPEN ACCESS SUTURE CAPTURING DEVICE MFJ BOSTON SCIENTIFIC CORPORATION M0068311251 11346463

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK