BEUDAMED
    FDA Adverse Event Death Summary report: N

    ASAP AUTOMATIC 15 GUAGE CORE BIOPSY SYSTEM

    MDR report key: 832 · Received July 7, 1992

    Report

    Report Number
    832
    Event Type
    Death
    Date Received
    July 7, 1992
    Date of Event
    May 29, 1992
    Report Date
    June 18, 1992
    Manufacturer
    MICROVASIVE/BOSTON SCIENTIFIC CORPORATION
    Product Code
    FCG
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    LIVER BIOPSY NEEDLE CAUSED A LACERATION TO LIVER, CAUSING INTRA-ABDOMINAL BLEEDING. LIVER HAD METASTASES/LARGE AREAS ON THE DOME OF LIVER - RIGHT LOBE. LACERATION WAS SURGICALLY REPAIRED BUT LIVER WAS TOO FRIABLE DUE TO CANCER. PATIENT EXPIRED. RESULTS OF AUTOPSY RECEIVED BY THIS FACILITY 67/17/92DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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.INVALID DATA - REGARDING EVALUATION BY USER AFTER EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: TELEMETRY FAILURE, INHERENT RISK OF PROCEDURE, PATIENT'S CONDITION - PREDISPOSED EVENT. CONCLUSION: DEVICE DISCARDED - UNABLE TO FOLLOW-UP, THERE WAS NO DEVICE FAILURE. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAP AUTOMATIC 15 GUAGE CORE BIOPSY SYSTEM FCG MICROVASIVE/BOSTON SCIENTIFIC CORPORATION H 60015

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death