BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    40CC INTRA-AORTIC BALLOON 9F CATHETER

    MDR report key: 859 · Received July 6, 1992

    Report

    Report Number
    859
    Event Type
    Malfunction
    Date Received
    July 6, 1992
    Date of Event
    June 17, 1992
    Report Date
    June 24, 1992
    Manufacturer
    KONTRON INSTRUMENTS, INC.
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT NEEDED IABP INTERVENTION. BALLOON CATHETER WAS INSERTED IN CVA AND THE PATIENT WAS MOVED TO CSR. THE CONSOLE ALARMED AFTER FIVE HOURS OF USE. THE PROBLEM WAS IDENTIFIED AS CATHETER RELATED AND THE CATHETER WAS REMOVED. IT WAS INSPECTED BY CCPS. CATHETER WAS FOUND TO WRAP ITSELF AND OCCLUDE HELIUM PATHWAYDEVICE 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: INVALID DATA. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 40CC INTRA-AORTIC BALLOON 9F CATHETER Implant INTRA-AORTIC BALLOON PUMP CATHETER DSP KONTRON INSTRUMENTS, INC. N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other