BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRAFLEX

    MDR report key: 18073702 · Received November 3, 2023

    Report

    Report Number
    MW5147763
    Event Type
    Death
    Date Received
    November 3, 2023
    Date of Event
    October 27, 2023
    Report Date
    October 30, 2023
    Manufacturer
    ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED)
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ULTRAFLEX 7.5FR 40 CC IAB(INTRA-AORTIC BALLOON) PLACED (B)(6) 2023 PRE-OP. DURING REMOVAL ON (B)(6) 2023 IN CCL (CARDIOVASCULAR "CATHETERIZATION" LAB), DIFFICULTY DEFLATING AND REMOVING IAB(CARDIOTHORACIC INTENSIVE CARE UNIT). EXCESSIVE BLEEDING TREATED WITH BALLOON FOR HEMOSTASIS AND TWO COVERED STENTS. PATIENT TRANSFERRED TO CTICU AND SUBSEQUENTLY DECLINED 3 HOURS AFTER PROCEDURE AND EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341213 ULTRAFLEX SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INCORPORATED) IAB-06840-U 18F23G0063

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Male Death