BEUDAMED
    FDA Adverse Event Other Summary report: N

    PERCLOSE

    MDR report key: 469350 · Received July 3, 2003

    Report

    Report Number
    469350
    Event Type
    Other
    Date Received
    July 3, 2003
    Date of Event
    June 12, 2003
    Report Date
    July 1, 2003
    Manufacturer
    PERCLOSE INC.
    Product Code
    MGB
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAILED PERCLOSE S/P CATH. PT DEVELOPED HEMATOMA/PSEUDO ANEURYSM HAD TO HAVE SURGICAL REPAIR OF PSEUDO.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 8/21/03: MODEL NUMBER 12337. MANUFACTURING LOT AND/OR SERIAL NUMBER UNK. THE DEVICE WAS NOT RETURN. THERE WAS NO LOT INFO PROVIDED THEREFORE A WORK ORDER REVIEW CANNOT BE PERFORMED. A ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFO PROVIDED. THE DATE THAT FIRM RECEIVED INFO ABOUT THE EVENT DESCRIBED IN THE MEDICAL DEVICE REPORT. 06/12/2003. THE DEVICE IS NOT BEING RETURNED FOR TESTING AND INVESTIGATION. THE DEVICE HAS BEEN SEQUESTERED BY THE FACILITY. CONCLUSION CODE 92 WAS DOCUMENTED IN THE INITIAL MDR BECAUSE A ROOT CAUSE CANNOT BE DETERMINED BASED ON THE INFO PROVIDED. THE DEVICE IS NOT BEING RETURNED FOR TESTING AND INVESTIGATION. THE DEVICE HAS BEEN SEQUESTERED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERCLOSE VASCULAR CLOSURE DEVICE MGB PERCLOSE INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other