BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRUITT AORTIC IRRIGATION OCCLUSION CATHETER

    MDR report key: 201743 · Received December 11, 1998

    Report

    Report Number
    201743
    Event Type
    Injury
    Date Received
    December 11, 1998
    Date of Event
    October 6, 1998
    Report Date
    October 21, 1998
    Manufacturer
    IFM
    Product Code
    DQT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING SURGICAL PROCEDURE, AORTO BIFEM BYPASS GRAFT, INSERTED PRUITT AORTIC BALLOON CATHETER AND INFLATED TO A TOTAL OF 25CC FLUID. BALLOON RUPTURED RESULTING IN MASSIVE BLEEDING WHICH WAS CONTROLLED (BY APPLICATION OF CLAMPS). RAPIDLY RESUSCITATED WITH CELL SAVER BLOOD (1000CC) AND 3U PRBC. OBTAINED HEMOSTASIS AND PROCEDURE CONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRUITT AORTIC IRRIGATION OCCLUSION CATHETER AORTIC BALLOON CATHETER DQT IFM 12F-10 1053097-15

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Required Intervention