BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBEROPTIX ULTRA 8 IAB: 8FR 30CC

    MDR report key: 14577508 · Received June 2, 2022

    Report

    Report Number
    3010532612-2022-00202
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    May 6, 2022
    Report Date
    May 6, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DSP
    UDI-DI
    00801902034724
    PMA / PMN Number
    K021462
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THERE IS AN INVESTIGATION ONGOING INTO THIS REPORTED COMPLAINT. A SUPPLEMENT FOLLOW-UP MDR REPORT WILL BE SUBMITTED WITH THE INVESTIGATION RESULTS UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED COMPLAINT OF IAB BLOOD IN HELIUM PATHWAY IS NOT ABLE TO BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. NO FURTHER ACTION REQUIRED AT THIS TIME. THE REPORTED COMPLAINT WILL BE MONITORED FOR ANY DEVELOPING TRENDS. IF THE PRODUCT IS RETURNED AT A LATER DATE, A FULL INVESTIGATION OF THE SAMPLE WILL BE COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REPRESENTATIVE (SR) THAT ONCE THE BALLOON WAS INSERTED, THE BALLOON WORKED INITIALLY BUT THEN BEGAN TO GET HIGH-PRESSURE ALARMS. THEN THE STAFF BEGAN GETTING HELIUM LOSS ALARMS. UPON WITHDRAWAL OF THE BALLOON, IT WAS MET WITH RESISTANCE. THE RIGHT FEMORAL ARTERY THEN BECAME TORN. THE PATIENT WAS TRANSFERRED TO THE OR FOR A FEMORAL ARTERY REPAIR.

    Description of Event or Problem · 0

    IT WAS REPORTED BY THE SALES REPRESENTATIVE (SR) THAT ONCE THE BALLOON WAS INSERTED, THE BALLOON WORKED INITIALLY BUT THEN BEGAN TO GET HIGH-PRESSURE ALARMS. THEN THE STAFF BEGAN GETTING HELIUM LOSS ALARMS. UPON WITHDRAWAL OF THE BALLOON, IT WAS MET WITH RESISTANCE. THE RIGHT FEMORAL ARTERY THEN BECAME TORN. THE PATIENT WAS TRANSFERRED TO THE OR FOR A FEMORAL ARTERY REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215801 FIBEROPTIX ULTRA 8 IAB: 8FR 30CC SYSTEM, BALLOON, INTRA-AORTIC DSP ARROW INTERNATIONAL LLC IPN000252 18F21H0003 00801902034724

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention