BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FFR LINK

    MDR report key: 24235774 · Received February 2, 2026

    Report

    Report Number
    2124215-2026-05789
    Event Type
    Malfunction
    Date Received
    February 2, 2026
    Date of Event
    November 4, 2025
    Report Date
    March 12, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    E1: INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL (B)(6). E1: INITIAL REPORTER PHONE: (B)(6). 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 CANCELLED/RESCHEDULED - POST SEDATION/SEDATION UNKNOWN (PROLONGED PROCEDURE MODERATE) 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 FFR LINK WAS KINKED AND HAD POOR CONTACT WAS MOST LIKELY DETERMINED TO BE FFR LINK POWER CORD WAS FRACTURED BASED ON THE BASED ON THE FIELD SERVICE ENGINEER (FSE) ANALYSIS ONSITE AND ADDITIONAL AVAILABLE INFORMATION.

    Additional Manufacturer Narrative · 0

    E1- INITIAL REPORTER FACILITY NAME: (B)(6) HOSPITAL. E1- INITIAL REPORTER PHONE: (B)(6). GOOD FAITH EFFORT ATTEMPTS WERE MADE TO TRY AND RETRIEVE ADDITIONAL DETAILS REGARDING THE REPORTED EVENT, BUT FURTHER INFORMATION WAS UNABLE TO BE OBTAINED. DETAILED PRODUCT INFORMATION WAS NOT PROVIDED TO BSC. WE COMPLETED A GOOD FAITH EFFORT TO OBTAIN THE INFORMATION. BECAUSE THE PRODUCT IS UNKNOWN AT THIS TIME, WE ARE UNABLE TO PROVIDE THE COMPLETE UNIQUE IDENTIFIER (UDI) # AND OTHER SPECIFIC PRODUCT INFORMATION. IF ADDITIONAL DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A FFR LINK WAS SELECTED FOR USE. DURING PREPARATION, OUTSIDE THE PATIENT, IT WAS NOTED THAT THE POWER CORD OF THE FFR LINK WAS KINKED, HAD POOR CONTACT, AND WAS NOT PROPERLY CONNECTED, WHICH PREVENTED THE PRESSURE GUIDEWIRE FROM BEING USED. AS A RESULT, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. A FFR LINK WAS SELECTED FOR USE. DURING PREPARATION, OUTSIDE THE PATIENT, IT WAS NOTED THAT THE POWER CORD OF THE FFR LINK WAS KINKED, HAD POOR CONTACT, AND WAS NOT PROPERLY CONNECTED, WHICH PREVENTED THE PRESSURE GUIDEWIRE FROM BEING USED. AS A RESULT, THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS, AND THE PATIENT WAS STABLE POST PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330306 FFR LINK PROGRAMMABLE DIAGNOSTIC COMPUTER, BLOOD PRESSURE COMPUTER DQK BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female