BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLOON PUMP CATHETER/40CC INTRA-AORTIC BALLOON OF CARDIOTHE

    MDR report key: 1405 · Received September 22, 1992

    Report

    Report Number
    1405
    Event Type
    Malfunction
    Date Received
    September 22, 1992
    Date of Event
    September 9, 1992
    Report Date
    September 15, 1992
    Manufacturer
    KONTRON INSTRUMENTS, INC.
    Product Code
    GBA
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    BALLOON CATHETER INSERTED;HEMOSTATIC CUFF SECURED TO INTRODUCER. BLOOD LEAKED AROUND CUFF/CATHETER INTERFACE. DR. PLACED SUTURE AROUND CUFF AND STOPPED FLOW OF BLOOD. OTHERWISE, CATHETER FUNCTIONED WITHOUT EVENT UNTIL PATIENT EXPIRED 9/10/92. BALLOON PUMP TIME OF 23 HOURSDEVICE 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.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: UNKNOWN (CANNOT DETERMINE). CORRECTIVE ACTIONS: DEVICE DISCARDED. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BALLOON PUMP CATHETER/40CC INTRA-AORTIC BALLOON OF CARDIOTHE Implant BALLOON PUMP CATHETER GBA KONTRON INSTRUMENTS, INC. N/A 060592

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other