BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AC3 OPTIMUS IABP TELEFLEX MEDICAL

    MDR report key: 12624479 · Received October 12, 2021

    Report

    Report Number
    MW5104561
    Event Type
    Injury
    Date Received
    October 12, 2021
    Date of Event
    October 5, 2021
    Report Date
    October 7, 2021
    Manufacturer
    ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED)
    Product Code
    DSP
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AN (B)(6) YEAR OLD FEMALE WITH SIGNIFICANT DEMENTIA THAT PRESENTED TO (B)(6) WITH CHEST PAIN AND WAS TAKEN EMERGENTLY TO THE CATH LAB FOR PCI/STENTING AND HAD AN IABP PLACED (ABOUT 1:15 PM ON 10/5). AT 21:00 ON (B)(6) 2021 THE RN NOTICED BLOOD FLECKS IN THE TUBING. THE BALLOON PUMP WAS STOPPED AT 22:00. AT 23:00 AT PHYSICIAN ATTEMPTED TO REMOVE THE BALLOON AT THE BESIDE BUT IT BECAME "STUCK". THE PATIENT WAS THEN TAKEN TO THE OPERATING ROOM TO HAVE IT SURGICALLY REMOVED. THERE IS A WOUND VAC IN PLACE AND THE DISTAL PULSES ARE GOOD. THE PATIENT IS RECOVERING. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1516386 AC3 OPTIMUS IABP TELEFLEX MEDICAL SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED) UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention