BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    P-6-110-CARDIAC-UHF-PERFORMA

    MDR report key: 217482 · Received March 30, 1999

    Report

    Report Number
    1628221-1999-00012
    Event Type
    Malfunction
    Date Received
    March 30, 1999
    Date of Event
    January 12, 1999
    Report Date
    March 2, 1999
    Manufacturer
    MALLINCKRODT MEDICAL, INC.
    Product Code
    DQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THIS CATHETER WAS BEING UTILIZED FOR A DIAGNOSTIC CARDIOLOGY PROCEDURE WHEN IT KINKED AT A SIDEHOLE DURING THE ATTEMPT TO ADVANCE INTO THE LEFT VENTRICLE. AN ATTEMPT TO STRAIGHTEN THE CATHETER WITH A GUIDEWIRE WAS UNSUCCESSFUL. THE GUIDWIRE WAS THEN PASSED THROUGH THE SIDEHOLE AND THE CATHETER WAS BACKED OUT OVER THE GUIDEWIRE TO THE AORTO-ILIAC BIFURCATION, STRAIGHTENED, AND REMOVED. THERE WAS NO INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 P-6-110-CARDIAC-UHF-PERFORMA DIAGNOSTIC INTRAVASCULAR CATHETER DQO MALLINCKRODT MEDICAL, INC. NA M368940

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other GUIDEWIRE