BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIOVASCULAR CATHETER

    MDR report key: 762 · Received June 23, 1992

    Report

    Report Number
    762
    Event Type
    Death
    Date Received
    June 23, 1992
    Date of Event
    May 26, 1992
    Report Date
    June 5, 1992
    Manufacturer
    CR BARD, INC.
    Product Code
    LFK
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A HEART CATHERIZATION. AT 1000 HE HAD AN ONSET OF CHEST PAIN. AT 1001 THE CATHETER WAS REMOVED LESS THE DISTAL 10CM WHICH HAD BROKEN OFF AND REMAINED LODGED IN THE RIGHT ILIAC OR FEMORAL ARTERY REGION. SHORTLY THEREAFTER THE DISTAL 10CMS OF CATHETER WAS RETRIEVED FROM THE RIGHT FEMORAL ARTERY. THE PATIENT WAS PRONOUNCED DEAD AT 1100. THE BROKEN CATHETER WAS FELT TO BE INCIDENTAL TO THE DEATHDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: FAIR CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: NO. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIOVASCULAR CATHETER POSITROL II, TAPERED TIP, JUDKINS RIGHT 4CM CURVE LFK CR BARD, INC. JR 4 7F 100CM 09 CC 1383

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Death