BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY PRO THORACIC STENT-GRAFT SYSTEM

    MDR report key: 12173169 · Received July 15, 2021

    Report

    Report Number
    2247858-2021-00062
    Event Type
    Malfunction
    Date Received
    July 15, 2021
    Date of Event
    June 21, 2021
    Report Date
    December 17, 2021
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY NBS PRO DEVICE. THE RELAY NBS PRO DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US IN 2012 (P110038). THE EVENT OCCURRED IN GERMANY. PLEASE NOTE - SINCE THE INITIAL MDR FILING, THE RELAY PRO THORACIC STENT-GRAFT SYSTEM HAS BEEN APPROVED BY THE FDA (P200045) ON AUGUST 5, 2021.

    Description of Event or Problem · 0

    FLUSH PORT DID NOT WORK PROPERLY. SALINE DID NOT COME OUT OF THE TIP. DEVICE WAS THEN DISCARDED AND A RELAY PLUS WITH THE SAME DIMENSIONS WAS USED INSTEAD. AFFECTED DEVICE WILL BE COLLECTED TO BE RETURNED FOR INVESTIGATION. PATIENT OUTCOME - "PROCEDURE WENT UNEVENTFUL. PATIENT IS DOING FINE."

    Additional Manufacturer Narrative · 1

    BOLTON MEDICAL IS VOLUNTARILY REPORTING AN EVENT RELATED TO A RELAY NBS PRO DEVICE. THE RELAY NBS PRO DEVICE IS NOT MARKETED IN THE US, HOWEVER IT IS SIMILAR TO THE RELAY THORACIC STENT GRAFT WITH PLUS DELIVERY SYSTEM APPROVED FOR SALE IN THE US IN 2012 (P110038). THE EVENT OCCURRED IN GERMANY.

    Description of Event or Problem · 1

    FLUSH PORT DID NOT WORK PROPERLY. SALINE DID NOT COME OUT OF THE TIP. DEVICE WAS THEN DISCARDED AND A RELAY PLUS WITH THE SAME DIMENSIONS WAS USED INSTEAD. AFFECTED DEVICE WILL BE COLLECTED TO BE RETURNED FOR INVESTIGATION. PATIENT OUTCOME - "PROCEDURE WENT UNEVENTFUL. PATIENT IS DOING FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1075470 RELAY PRO THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B210322276

    Patients

    Seq Age Sex Outcome Treatment
    1 00 YR Unknown