BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMPSON CORONARY AATHEROCATH SCA-EX

    MDR report key: 6897 · Received November 12, 1993

    Report

    Report Number
    6897
    Event Type
    Death
    Date Received
    November 12, 1993
    Date of Event
    October 6, 1993
    Report Date
    October 15, 1993
    Manufacturer
    DEVICES FOR VASCULAR INTERVENTION, INC.
    Product Code
    MCX
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    A PERFORATION OF THE PT'S LEFT ANTERIOR DESCENDING ARTERY OCCURRED DURING A DIRECTIONAL CORONARY ARTHERECTOMY. THE ARTERIAL PERFORATION RESULTED IN CARDIAC TAMPONADE. THE PT WAS MOVED TO THE OR AND UNDERWENT SUCCESSFUL CORONARY ARTERY BYPASS GRAFT SURGERY. THE PT DIED 10/13/93.DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS MULTIPLE PATIENT INVOLVEMENT. NUMBER OF PATIENTS INVOLVED: 2.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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: USE OF ALL SIMILAR DEVICES STOPPED TEMPORARILY. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPSON CORONARY AATHEROCATH SCA-EX MCX DEVICES FOR VASCULAR INTERVENTION, INC. 7F9MM UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death