BEUDAMED
    FDA Adverse Event Death Summary report: N

    CARDIAC ASSIST. PERCOR PERCUTANEOUS INTRODUCER W/HEMOSTATIS

    MDR report key: 384 · Received February 19, 1992

    Report

    Report Number
    384
    Event Type
    Death
    Date Received
    February 19, 1992
    Date of Event
    December 20, 1991
    Report Date
    February 6, 1992
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON 12/20/91, DURING CARDIAC CATHETERIZATION THE EXTERNAL ILIAC ARTERY WAS PUNCTURED BY A PERCUTANEOUS INTRODUCER DURING PLACEMENT OF AN INTRA-AORTIC BALLOON. WHEN THE BALLOON WAS REMOVED ON 12/22/91, EXSANGUINATION OCCURRED AND PATIENT EXPIRED. PATIENT HAD SEVERE CORONARY ARTERY DISEASE PREDISPOSING HER TO THIS COMPLICATION. THIS ISSUE WAS BROUGHT TO OUR ATTENTION ON 1/30/92 AND IT WAS DETERMINED THAT A DEVICE WAS INVOLVED ON 1/31/92INVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. PATIENT MEDICAL STATUS PRIOR TO EVENT: INVALID DATA. 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. INVALID DATA - WHETHER DEVICE USED AS LABELED/INTENDED. INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: INVALID DATA. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: INVALID DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NO DATA. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CARDIAC ASSIST. PERCOR PERCUTANEOUS INTRODUCER W/HEMOSTATIS PERCUTANEOUS INTRODUCER W/ HEMOSTATIS VALVE DYB DATASCOPE CORPORATION 0684-00-0210

    Patients

    Seq Age Sex Outcome Treatment
    1 Death