BEUDAMED
    FDA Adverse Event Death Summary report: N

    N/A

    MDR report key: 668 · Received June 9, 1992

    Report

    Report Number
    668
    Event Type
    Death
    Date Received
    June 9, 1992
    Date of Event
    March 7, 1992
    Report Date
    May 29, 1992
    Manufacturer
    KONTRON INSTRUMENTS
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    THIS PATIENT WAS ADMITTED TO MOUNT SINAI HOSPITAL STATUS POST MYOCARDIAL INFARCTION AND CONGESTIVE HEART FAILURE FOR CORONARY ARTERY BYPASS, WHICH WAS PERFORMED ON 3/6/92. IN VIEW OF REDUCED VENTRICULAR VOLUME AND DECREASED CARDIAC FUNCTION IT WAS DECIDED TO INSERT AN INTRAAORTIC BALLOON PUMP (IABP). THE FOLLOWING DAY, A SMALL AMOUNT OF BLOOD WAS NOTED IN THE IABP PRESSURE LINE. A FEW HOURS LATER, THERE WAS DIFFICULTY MAINTAINING SATISFACTORILY SEQUENCING OF THE BALLOON. SINCE THE PATIENT APPEARED STABLE, IT WAS ELECTED TO REMOVE THE BALLOON. AFTER EXPOSING THE BALLOON INSERTION SITE, THE PHYSICIAN EXPERIENCED SOME RESISTANCE WHEN TRACTION WAS APPLIED. THE ARTERIOTOMY SITE WAS ENLARGED AND TRACTION REAPPLIED. THE PATIENT BECAME SEVERELY HYPOTENSIVE, REQUIRING A STERNOTOMY AND CARDIAC MASSAGE, UNFORTUNATELY, THE PATIENT SUCCUMBED. PRELIMINARY REVIEW OF THIS CASE AND AUTOSPY FINDING INDICATED THAT THERE WAS TRAUMA TO THE INTRA-AORTIC BALLOON, BY A SHARP "KNIFE LIKE" PLAQUE IN THE PATIENT'S AORTA. SUBSEQUENT ANALYSIS BY DEPARTMENTAL PEER REVIEW AND EXECUTIVE COMMITTEE CONCLUDED THAT THE EXCESSIVE USE OF FORCE APPLIED BY THE RESIDENT WHEN REMOVING THE INTRA AORTIC BALLOON WAS RESPONSIBLE FOR THE TEAR IN THE VESSEL, THE RESULTS OF WHICH IMPACTED UPON THE DEMISE OF THE PATIENT. THE RESULTS OF THE EVALUATION OF THE EQUIPMENT ITSELF, BY THE MANUFACTURER, REMAINS PENDING AT THIS TIMEDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: CRITICAL 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: INVALID DATA. CONCLUSION: THERE WAS NO DEVICE FAILURE, USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, USER EDUCATION PROVIDED. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 N/A Implant INTRA-AORTIC BALLOON CATHETER 9.0 FRENCH, 40CC DOUBLE LUMEN DSP KONTRON INSTRUMENTS 0021-4240 080691

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death