BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    40CC INTRA-AORTIC BALLOON 9F CATHETER

    MDR report key: 856 · Received July 6, 1992

    Report

    Report Number
    856
    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 REQUIRED IABP INTERVENTION. THE BALLOON WAS INSERTED, FAILED TO FUNCTION, WAS REMOVED, AND A SECOND CATHETER INSERTED (WHICH WORKED). THE CATHETER WAS TRASHED BEFORE IT COULD BE RETAINEDDEVICE 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. INVALID DATA - WHETHER 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. THE DEVICE WAS DESTROYED/DISPOSED OF.

    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. 040392

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other