BEUDAMED
    FDA Adverse Event Death Summary report: N

    IABP FIBEROPTIC AIB

    MDR report key: 21926421 · Received April 29, 2025

    Report

    Report Number
    MW5169609
    Event Type
    Death
    Date Received
    April 29, 2025
    Date of Event
    January 22, 2025
    Report Date
    March 24, 2025
    Manufacturer
    ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED)
    Product Code
    DSP
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IABP ALARMED FOR HELIUM LOSE AND SPOKE WITH TELEFLEX REGARDING SPECKS OF BLOOD ALONG THE TUBING. TELEFLEX ADVISED BALLOON RUPTURE AS EVIDENCED BY BLOOD SPECKS IN THE HELIUM TUBING. UNSUCCESSFUL ATTEMPTS TO REMOVE IABP CATHETER X 2 AND PT TAKEN EMERGENTLY TO THE OPERATING ROOM FOR REMOVAL AND REPAIR OF FEMORAL ARTERY. SURGERY SUCCESSFUL BUT PT DIED THE FOLLOWING DAY AND UNABLE TO EXCLUDE NEED FOR SURGICAL REMOVAL OF CATHETER AS A CONTRIBUTING FACTOR FOR PREVIOUSLY UNSTABLE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1596236 IABP FIBEROPTIC AIB SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED) 8F 40CC

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other| H| D