BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FFR LINK

    MDR report key: 20780329 · Received November 26, 2024

    Report

    Report Number
    2124215-2024-74340
    Event Type
    Malfunction
    Date Received
    November 26, 2024
    Date of Event
    November 8, 2024
    Report Date
    March 9, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    08714729890010
    PMA / PMN Number
    K151613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: DEVICE ANALYSIS FINDINGS: THE DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A TECHNICAL ANALYSIS COULD NOT BE PERFORMED. RISK REVIEW IF COMPLETED: A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENT OF POWER CORD DAMAGE/DEFECTIVE (POWER SUPPLY FAILURE) WAS DEFINED IN THE RISK DOCUMENTATION. THESE EVENT TYPE HAVE BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. INVESTIGATION CONCLUSION: THIS INVESTIGATION IS ASSIGNED AN INVESTIGATION CONCLUSION CODE OF CAUSE TRACED TO COMPONENT FAILURE. THIS CONCLUSION WAS SELECTED BECAUSE THE REASON FOR THE POWER CORD WAS BROKEN WAS MOST LIKELY DETERMINED TO BE THE POWER CORD THE FIELD SERVICE ENGINEER (FSE) ANALYSIS ONSITE. FURTHERMORE, FIELD SERVICE ENGINEER (FSE) REPLACED OF THE POWER CORD HAS RESOLVED THE COMPLAINT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE FFR LINK WAS SELECTED FOR TREATMENT. HOWEVER, THE POWER CODE WAS FOUND BROKEN AND THE DEVICE COULD NOT BE TURNED ON. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS IN GOOD CONDITION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE FFR LINK WAS SELECTED FOR TREATMENT. HOWEVER, THE POWER CODE WAS FOUND BROKEN AND THE DEVICE COULD NOT BE TURNED ON. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS IN GOOD CONDITION. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS NOT CANCELLED. IT WAS COMPLETED WITH OTHER EQUIPMENT AND THE PATIENT WAS UNDER LOCAL ANESTHESIA.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. THE FFR LINK WAS SELECTED FOR TREATMENT. HOWEVER, THE POWER CODE WAS FOUND BROKEN AND THE DEVICE COULD NOT BE TURNED ON. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT WAS IN GOOD CONDITION. IT WAS FURTHER REPORTED THAT THE PROCEDURE WAS NOT CANCELLED. IT WAS COMPLETED WITH OTHER EQUIPMENT AND THE PATIENT WAS UNDER LOCAL ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227601 FFR LINK PROGRAMMABLE DIAGNOSTIC COMPUTER, BLOOD PRESSURE COMPUTER DQK BOSTON SCIENTIFIC CORPORATION H7495551000 SPM05937 08714729890010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown