BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERCLOSE

    MDR report key: 577562 · Received February 28, 2005

    Report

    Report Number
    MW1034769
    Event Type
    Other
    Date Received
    February 28, 2005
    Date of Event
    January 21, 2005
    Report Date
    January 21, 2005
    Manufacturer
    *
    Product Code
    MGB
    Report Source
    Voluntary report
    Reporter Location
    SC, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS LIST NUMBER OF THE DEVICE IS 12673. THE LOT NUMBER OF THE DEVICE IS 20137-6H. A MORE COMPLETE DESCRIPTION OF THE EVENT COULD NOT BE OBTAINED. MULTIPLE ATTEMPTS WERE MADE TO THE RISK MGR ON 3/7/2005, 3/10/2005 AND 3/14/2005 WITH NO RESPONSE. THEREFORE, CO WAS UNABLE TO OBTAIN ANY ADDITIONAL INFO. ACCORDING TO THE DESCRIPTION OF THE EVENT (VIA THE USER FACILITY MEDWATCH FORM), THE DEVICE EXPERIENCED A CUFF MISS. FAILURE ANALYSIS OF THE DEVICE COULD NOT BE PERFORMED, AS THE DEVICE WAS NOT RETURNED FOR EVAL. THE LOT NUMBER WAS PROVIDED. THE DEVICE HISTORY RECORD WAS REVIEWED AND NO DEVIATIONS WERE FOUND RELEVANT TO THIS INVESTIGATION. THE DATE OF THE EVENT WAS 2005. ABBOTT VASCULAR DEVICES WAS MADE AWARE OF THIS EVENT ON 2/25/2005. A COMPLETE INVESTIGATION, PER CO PROCEDURES, DETERMINED THAT THIS EVENT DID NOT MEET THE CRITERIA OF A REPORTABLE EVENT. THEREFORE, A MEDICAL DEVICE REPORT WAS NOT FILED. ALTHOUGH THE USER FACILITY MEDWATCH INDICATES THAT THE DEVICE IS AVAILABLE FOR EVAL, IT HAS NOT BEEN RETURNED TO THE FACILITY FOR DEVICE ANALYSIS. THE DISPOSITION OF THE DEVICE IS UNK.

    Description of Event or Problem · 1

    PERCLOSE UNSUCCESSFUL AS STATED BY MD. MD STATED THAT THE SUTURES FAILED TO CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE PERCLOSE MGB * * 20137-6H

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Other