BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY NBS PRO THORACIC STENT-GRAFT SYSTEM

    MDR report key: 12129585 · Received July 7, 2021

    Report

    Report Number
    2247858-2021-00059
    Event Type
    Malfunction
    Date Received
    July 7, 2021
    Date of Event
    June 9, 2021
    Report Date
    December 10, 2021
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P110038
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    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 SPAIN.

    Description of Event or Problem · 0

    THE FLUSH PORT VALVE WAS BROKEN. WHEN SERUM WAS INJECTED THROUGH THE FLUSH PORT TO PURGE THE DELIVERY SYSTEM, IT WAS DETECTED THAT SERUM WAS COMING OUT THROUGH THE VALVE. THEY TRIED TO BLOCK THE HOLE WHERE THE SERUM WAS COMING OUT, BUT THEY COULD NOT GET IT. SINCE THE SERUM WAS ALSO COMING OUT OF THE TIP OF THE DELIVERY SYSTEM, THE SYSTEM COULD BE WASH OUT. ONCE THE DELIVERY SYSTEM WAS INTRODUCED INTO THE PATIENT, IT WAS NECESSARY TO USE A CLAMP TO BLOCK THE FLUSH PORT, BECAUSE THE BLOOD WAS COMING OUT THROUGH IT. IN THIS WAY, THE IMPLANT COULD BE PERFORMED WITHOUT FURTHER INCIDENT. PATIENT OUTCOME - "PATIENT DID NOT SHOW ANY INJURED OR IMMEDIATE CONSEQUENCE."

    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 (B)(6).

    Description of Event or Problem · 1

    THE FLUSH PORT VALVE WAS BROKEN. WHEN SERUM WAS INJECTED THROUGH THE FLUSH PORT TO PURGE THE DELIVERY SYSTEM, IT WAS DETECTED THAT SERUM WAS COMING OUT THROUGH THE VALVE. THEY TRIED TO BLOCK THE HOLE WHERE THE SERUM WAS COMING OUT, BUT THEY COULD NOT GET IT. SINCE THE SERUM WAS ALSO COMING OUT OF THE TIP OF THE DELIVERY SYSTEM, THE SYSTEM COULD BE WASH OUT. ONCE THE DELIVERY SYSTEM WAS INTRODUCED INTO THE PATIENT, IT WAS NECESSARY TO USE A CLAMP TO BLOCK THE FLUSH PORT, BECAUSE THE BLOOD WAS COMING OUT THROUGH IT. IN THIS WAY, THE IMPLANT COULD BE PERFORMED WITHOUT FURTHER INCIDENT. PATIENT OUTCOME - "PATIENT DID NOT SHOW ANY INJURED OR IMMEDIATE CONSEQUENCE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1029320 RELAY NBS PRO THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. B201215286

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Unknown