BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-AORTIC BALLOON CATHETER

    MDR report key: 5634 · Received July 13, 1993

    Report

    Report Number
    5634
    Event Type
    Malfunction
    Date Received
    July 13, 1993
    Date of Event
    June 15, 1993
    Report Date
    June 30, 1993
    Manufacturer
    KONTRON INSTRUMENT, INC.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    CATHETER WAS IN PATIENT FOR APPROXIMATELY 33 HOURS AND DEVELOPED A PIN-HOLE IN MEEMBERANE. CATHETER HAD TO BE IMMEDIATELY REPLACED. PATIENT HAD NO ADVERSE EFFECT FROM CATHETER FAILURE. 12 HOURS BEFORE FAILURE, PATIENT MOMENTARILY SAT UP ON HIS OWNINVALID DATA - REGARDING SINGLE USE LABELING OF DEVICE. 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, MECHANICAL TESTS PERFORMED. RESULTS OF EVALUATION: COMPONENT FAILURE, BALLOON, MEMBRANE. CONCLUSION: DEVICE FAILURE OCCURRED AND WAS RELATED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALLOON CATHETER INTRA-AORTIC BALLOON CATHETER DSP KONTRON INSTRUMENT, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Other