BEUDAMED
    FDA Adverse Event Death Summary report: N

    ULTRAFLEX IAB: 7.5FR 40CC

    MDR report key: 12821878 · Received November 16, 2021

    Report

    Report Number
    3010532612-2021-00342
    Event Type
    Death
    Date Received
    November 16, 2021
    Date of Event
    October 2, 2021
    Report Date
    October 18, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DSP
    UDI-DI
    00801902026804
    PMA / PMN Number
    K000729
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. THE REPORTED COMPLAINT THAT THE "BALLOON BURST DURING IABP THERAPY AFTER 10 HOURS" IS NOT ABLE TO BE CONFIRMED. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. TELEFLEX ASSESSED THE RISK FOR THE REPORTED COMPLAINT. THERE ARE NO NEW OR REVISED RISK. THIS WILL BE MONITORED FOR ANY DEVELOPING TRENDS.

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Description of Event or Problem · 0

    THIS COMPLAINT WAS RECEIVED FROM MHRA. IT WAS REPORTED THAT THE BALLOON BURST DURING IABP THERAPY AFTER 10 HOURS. AS THE BALLOON WAS BEING REMOVED, THE BALLOON GOT STUCK AND HAD TO BE REMOVED VIA VASCULAR SURGERY. THERE WAS A REPORT OF PATIENT DEATH. THE PATIENT DIED OF CARDIAC CAUSES (CORONARY ARTERY DISEASE AND CARDIOGENIC SHOCK) FEW DAYS AFTER. ADDITIONAL INFORMATION WAS RECEIVED BY (B)(4) 11/03/2021. DR (B)(6) ALLEGE THAT THE DEVICE FAILURE CONTRIBUTED TO THE PATIENT DEATH.

    Description of Event or Problem · 0

    THIS COMPLAINT WAS RECEIVED FROM (B)(6). IT WAS REPORTED THAT THE BALLOON BURST DURING IABP THERAPY AFTER 10 HOURS. AS THE BALLOON WAS BEING REMOVED, THE BALLOON GOT STUCK AND HAD TO BE REMOVED VIA VASCULAR SURGERY. THERE WAS A REPORT OF PATIENT DEATH. THE PATIENT DIED OF CARDIAC CAUSES (CORONARY ARTERY DISEASE AND CARDIOGENIC SHOCK) FEW DAYS AFTER. ADDITIONAL INFORMATION WAS RECEIVED BY (B)(6) 11/03/2021. DR (B)(6) AND DR (B)(6)ALLEGE THAT THE DEVICE FAILURE CONTRIBUTED TO THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1718907 ULTRAFLEX IAB: 7.5FR 40CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL INC. IPN039793 18F21D0021 00801902026804

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death