BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBEROPTIX ULTRA 8 LAB--8FR 30CC

    MDR report key: 19932330 · Received August 6, 2024

    Report

    Report Number
    MW5158077
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    July 19, 2024
    Report Date
    August 2, 2024
    Manufacturer
    ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED)
    Product Code
    DSP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PT. HAD INSERTION OF AN IAB PUMP ON (B)(6) 2024. THE BALLOON FAILED POSTOPERATIVELY AND THE PATIENT DEVELOPED RLE ISCHEMIA. THE CATHETER WAS REMOVED. ON (B)(6) 2024 SHE WAS RETURNED TO SURGERY FOR URGENT RLE THROMBECTOMY AND FASCIOTOMIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1531595 FIBEROPTIX ULTRA 8 LAB--8FR 30CC SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP ARROW INTERNATIONAL, LLC (SUBSIDIARY OF TELEFLEX, INCORPORATED) IAB-05830-U 18F23H0060

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Required Intervention