BEUDAMED
    FDA Adverse Event Death Summary report: N

    TELEFLEX IABP BALLOON PUMP

    MDR report key: 20952914 · Received December 16, 2024

    Report

    Report Number
    MW5163660
    Event Type
    Death
    Date Received
    December 16, 2024
    Date of Event
    December 7, 2024
    Report Date
    December 12, 2024
    Manufacturer
    ARROW INTERNATIONAL, LLC. (SUBSIDIARY OF TELEFLEX, INCORPORATED)
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WITH STEMI(ST ELEVATION MYOCARDIAL INFARCTION) REQUIRED THE INSERTION OF INTRA AORTIC BALLOON PUMP PRIOR TO CORONARY ARTERY BYPASS GRAFTING. POST SURGERY WHILE IN ICU BLOOD WAS NOTED IN TUBING OF BALLOON PUMP INDICATING BALLOON RUPTURE. APPROPRIATE STEPS TAKEN AND BALLOON PUMP REMOVED BY CARDIOLOGIST. UPON EXAMINATION THERE WERE MULTIPLE TEARS IN THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    239062 TELEFLEX IABP BALLOON PUMP SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP ARROW INTERNATIONAL, LLC. (SUBSIDIARY OF TELEFLEX, INCORPORATED) IAB-05840-LWS-SC

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Death| L