BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBEROPTIX ULTRA 8 IAB: 8FR 40CC

    MDR report key: 14376332 · Received May 12, 2022

    Report

    Report Number
    3010532612-2022-00205
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    April 12, 2022
    Report Date
    April 13, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    00801902007247
    PMA / PMN Number
    K021462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    QN# (B)(4). TELEFLEX RECEIVED THE DEVICE FOR INVESTIGATION. THE REPORTED COMPLAINT OF IAB BLOOD IN HELIUM PATHWAY IS CONFIRMED. A PUNCTURE TO THE BLADDER, CONSISTENT WITH CONTACT FROM THE BROKEN FIBER, WAS FOUND NEAR THE DISTAL TIP OF THE CATHETER WHICH ALLOWED BLOOD TO ENTER THE HELIUM PATHWAY. THE ROOT CAUSE OF THE BROKEN FIBER 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) BROKE 24 HOURS AFTER THE INSERTION INTO THE PATIENT. AS A RESULT, ANOTHER IAB WAS USED, AND INSERTED AT A DIFFERENT INSERTION SITE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRA-AORTIC BALLOON (IAB) BROKE 24 HOURS AFTER THE INSERTION INTO THE PATIENT. AS A RESULT, ANOTHER IAB WAS USED, AND INSERTED AT A DIFFERENT INSERTION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2311086 FIBEROPTIX ULTRA 8 IAB: 8FR 40CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN039792 18F21H0009 00801902007247

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention