BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACS RX STREAK 014

    MDR report key: 5171 · Received May 17, 1993

    Report

    Report Number
    5171
    Event Type
    Death
    Date Received
    May 17, 1993
    Date of Event
    April 28, 1993
    Report Date
    May 3, 1993
    Manufacturer
    ADVANCED CARDIOVASCULAR SYSTEMS
    Product Code
    MFB
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING A CARDIAC ANGIOPLASTY, A PIECE OF THE TIP OF THE CATHETER BECAME SEPERATEDX AND TRAVELED UNTIL IT BECAME LODGED IN AN ARTERY. THE PATIENT EXPIRED. THE EVENT WAS RECORDED ON FLOUROSCOPY FILMDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. INVALID DATA - REGARDING 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INADEQUATE QUALITY ASSURANCE, TELEMETRY FAILURE, BALLOON. CONCLUSION: DEVICE FAILURE DIRECTLY CAUSED EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS RX STREAK 014 CORONARY DILATION CATHETER MFB ADVANCED CARDIOVASCULAR SYSTEMS 2.5 X 20 ASPIRATION 3030851

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death