BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-AORTIC BALLOON CATHETER, 40 CC, 9.0 FR.

    MDR report key: 7943 · Received April 5, 1994

    Report

    Report Number
    7943
    Event Type
    Malfunction
    Date Received
    April 5, 1994
    Date of Event
    August 5, 1993
    Report Date
    March 23, 1994
    Manufacturer
    KONTRON INSTRUMENTS, INC.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    ON 8/3/93, INTRA-AORTIC BALLOON CATHETER WAS INSERTED FOR TRIPLE VESSEL BYPASS. ON 8/4/93, PT EXPERIENCED CARDIAC TAMPONADE AND ISCHEMIA IN RIGHT LEG AFTER BALLOON CATHETER PLACEMENT. PT SENT TO OR FOR EVACUATION OF PERICARDIAL CLOT, ATTEMPTED TRANSTHORACIC BALLOON CATHETER PLACEMENT (NOT SUCCESSFUL), AND ASCENDING AORTA TO SUPERFICIAL FEMORAL ARTERY BYPASS. ON 8/5/93, IAP CATHETER, INSERTED 8/3/93, NOTED TO BE BACKFLOWED WITH BLOOD INDICATIVE OF BALLOON RUPTURE. CATHETER REMOVED AND REPLACED. PT EXPIRED LATER THE SAME DAY.DEVICE 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 NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALLOON CATHETER, 40 CC, 9.0 FR. Implant DSP KONTRON INSTRUMENTS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Other