BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KONTRON INTRA-AORTIC BALLOON CATHETER

    MDR report key: 3900 · Received February 19, 1993

    Report

    Report Number
    3900
    Event Type
    Malfunction
    Date Received
    February 19, 1993
    Date of Event
    June 18, 1992
    Report Date
    December 18, 1992
    Manufacturer
    KONTRON INSTRUMENTS, INC.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    A BLADDER LEAK OCCURRED IN AN INTRA-AORTIC BALLOON CATHETER 24 HOURS AFTER INSERTION.NOTE: KONTRON WAS NOTIFIED AND PERFORMED TESTING ON THE AFFECTED BALLOON.DEVICE 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 EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, PERFORMANCE TESTS PERFORMED. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: DEVICE EVALUATED AND ALLEGED FAILURE COULD NOT BE DUPLICATED. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR. THE DEVICE WAS NOT DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KONTRON INTRA-AORTIC BALLOON CATHETER Implant INTRA-AORTIC BALLOON CATHETER DSP KONTRON INSTRUMENTS, INC. MRA #7806

    Patients

    Seq Age Sex Outcome Treatment
    1 Other