BEUDAMED
    FDA Adverse Event Other Summary report: N

    INTRA-AORTIC BALLOON CATHETER

    MDR report key: 209815 · Received February 9, 1999

    Report

    Report Number
    2248146-1999-00003
    Event Type
    Other
    Date Received
    February 9, 1999
    Date of Event
    December 31, 1998
    Report Date
    January 22, 1999
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    ON 1/22/99, DATASCOPE REC'D THE MANDATORY MEDWATCH FORM FROM THE USER FACILITY AND THE FOLLOWING INFO WAS REPORTED: THE "BLOOD AT CATHETER TIP" ALARM SOUNDED FROM THE PUMP. NO BLOOD WAS NOTED AND THE PUMP WAS TURNED OFF. THE PUMP WAS RESTARTED AND UPON REFILLING AFTER AN ATTEMPT TO START PUMPING, THE "GAS LOSS LEAK" ALARM SOUNDED FROM THE PUMP. THEN, BLOOD WAS NOTED IN THE TUBING AND THE BALLOON WAS REMOVED. POST REMOVAL, THE PT DEVELOPED RESPIRATORY DISTRESS AND REQUIRED INTUBATION AND VENTILATORY SUPPORT. A SECOND IAB WAS INSERTED AND PUMPING WAS RESTARTED. THE IAB WAS NOT RETURNED TO DATASCOPE FOR EVALUATION. THE IAB WAS DISCARDED BY THE FACILITY. (EVENT COMPLICATIONS: RESPIRATORY DISTRESS - REPORTED 1/22/99.) (PT'S CURRENT STATUS: UNK - REPORTED 1/22/99).

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other