BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTRA-AORTIC BALLOON CATHETER

    MDR report key: 109365 · Received July 25, 1997

    Report

    Report Number
    2248146-1997-00747
    Event Type
    Malfunction
    Date Received
    July 25, 1997
    Report Date
    June 30, 1997
    Manufacturer
    DATASCOPE CORPORATION
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE QUALITY ASSURANCE DEPARTMENT OF DATASCOPE CORPORATION'S CARDIAC ASSIST DIVISION BECAME AWARE OF IAB BALLOON LEAK EVENTS OCCURING BETWEEN SEPTEMBER 1990 THROUGH FEBRUARY 1991. THE INFORMATION WAS REPORTED IN THE 1995 ISSUE OF "CHEST"; VOLUME. 108, PAGES 1495-1496. THE IABS IN QUESTION WERE NOT RETURNED TO DATASCOE. THIS IS LITERATURE REFERENCE ONLY. NO FURTHER INFORMATION IS AVAILABLE. (EVENT COMPLICATIONS: UNKNOWN. (PT'S CURRENT STATUS: UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTRA-AORTIC BALLOON CATHETER INTRA-AORTIC BALLON CATHETER DSP DATASCOPE CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN