BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RELAY PRO THORACIC STENT-GRAFT SYSTEM

    MDR report key: 12864272 · Received November 23, 2021

    Report

    Report Number
    2247858-2021-00113
    Event Type
    Malfunction
    Date Received
    November 23, 2021
    Date of Event
    October 26, 2021
    Report Date
    June 13, 2022
    Manufacturer
    BOLTON MEDICAL, INC.
    Product Code
    MIH
    PMA / PMN Number
    P200045
    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 A DEVICE MALFUNCTION RELATED TO A CUSTOM MADE RELAY PRO DEVICE. THE CUSTOM MADE RELAY PRO DEVICE IS NOT MARKETED IN THE US; HOWEVER IT IS SIMILAR TO THE RELAY PRO THORACIC STENT GRAFT SYSTEM APPROVED FOR SALE IN THE US (P200045). THE CUSTOM MADE RELATED EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 0

    BOLTON MEDICAL IS VOLUNTARILY REPORTING A DEVICE MALFUNCTION RELATED TO A CUSTOM MADE RELAY PRO DEVICE. THE CUSTOM MADE RELAY PRO DEVICE IS NOT MARKETED IN THE US; HOWEVER IT IS SIMILAR TO THE RELAY PRO THORACIC STENT GRAFT SYSTEM APPROVED FOR SALE IN THE US (P200045). THE CUSTOM MADE RELATED EVENT OCCURRED IN GERMANY.

    Description of Event or Problem · 0

    IN POSITION #1 THE PHYSICIAN WAS TURNING THE BLACK GRIP CLOCK-WISE TO ADVANCE THE INNER SHEATH WITHOUT COMPLAINING THAT THERE IS A LOT OF FORCE. AFTER SOME ROTATIONS WE LISTEN A LOUD CRACK-SOUND. TAKING A CLOSER LOOK ON THE X-RAY WE RECOGNIZED THAT THE OUTER SHEATH IS STILL COMPLETELY AROUND THE INNER SHEATH AND THAT THE OUTER SHEATH IS RETRACTED FROM THE HANDLE. AFTER THIS THE PHYSICIAN REMOVED THE WHOLE SYSTEM WITHOUT ANY PROBLEMS AND STOPPED THE PROCEDURE. PATIENT OUTCOME - "PATIENT WOKE UP WELL FROM ANESTHESIA."

    Description of Event or Problem · 0

    IN POSITION #1 THE PHYSICIAN WAS TURNING THE BLACK GRIP CLOCK-WISE TO ADVANCE THE INNER SHEATH WITHOUT COMPLAINING THAT THERE IS A LOT OF FORCE. AFTER SOME ROTATIONS WE LISTEN A LOUD CRACK-SOUND. TAKING A CLOSER LOOK ON THE X-RAY WE RECOGNIZED THAT THE OUTER SHEATH IS STILL COMPLETELY AROUND THE INNER SHEATH AND THAT THE OUTER SHEATH IS RETRACTED FROM THE HANDLE. AFTER THIS THE PHYSICIAN REMOVED THE WHOLE SYSTEM WITHOUT ANY PROBLEMS AND STOPPED THE PROCEDURE. PATIENT OUTCOME - "PATIENT WOKE UP WELL FROM ANESTHESIA."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1764135 RELAY PRO THORACIC STENT-GRAFT SYSTEM STENT, ENDOVASCULAR GRAFT, AORTIC MIH BOLTON MEDICAL, INC. 2109170244

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male