BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FFR LINK

    MDR report key: 21808571 · Received April 9, 2025

    Report

    Report Number
    2124215-2025-22102
    Event Type
    Malfunction
    Date Received
    April 9, 2025
    Date of Event
    March 25, 2025
    Report Date
    April 29, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQK
    UDI-DI
    08714729939603
    PMA / PMN Number
    K151613
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RETURNED PRODUCT CONSISTED OF THE FFR LINK. A VISUAL INSPECTION OF THE DEVICE REVEALED IT WAS IN GOOD CONDITION. WHEN THE DEVICE WAS PUT THROUGH FUNCTIONAL TESTING, IT DID NOT FAIL ANY OF THE STEPS. THE LAB WAS NOT ABLE TO CONFIRM THE REPORTED EVENTS, AS THE INVESTIGATION REVEALED NO DAMAGES OR DEFICIENCIES.

    Additional Manufacturer Narrative · 0

    E1 INITIAL REPORTER ADDRESS: (B)(6). THE RETURNED PRODUCT CONSISTED OF THE FFR LINK. A VISUAL INSPECTION OF THE DEVICE REVEALED IT WAS IN GOOD CONDITION. WHEN THE DEVICE WAS PUT THROUGH FUNCTIONAL TESTING, IT DID NOT FAIL ANY OF THE STEPS. THE LAB WAS NOT ABLE TO CONFIRM THE REPORTED EVENTS, AS THE INVESTIGATION REVEALED NO DAMAGES OR DEFICIENCIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN FFR LINK WAS SELECTED FOR EXAMINATION OF THE TARGET LESION. DURING USE, THE DEVICE EXPERIENCED AN ERROR AND WAS UNABLE TO SEND WAVEFORMS. BECAUSE OF THIS, THE PROCEDURE WAS NOT ABLE TO BE COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN FFR LINK WAS SELECTED FOR EXAMINATION OF THE TARGET LESION. DURING USE, THE DEVICE EXPERIENCED AN ERROR AND WAS UNABLE TO SEND WAVEFORMS. BECAUSE OF THIS, THE PROCEDURE WAS NOT ABLE TO BE COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PROCEDURE WAS CANCELLED. AN FFR LINK WAS SELECTED FOR EXAMINATION OF THE TARGET LESION. DURING USE, THE DEVICE EXPERIENCED AN ERROR AND WAS UNABLE TO SEND WAVEFORMS. BECAUSE OF THIS, THE PROCEDURE WAS NOT ABLE TO BE COMPLETED. THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624524 FFR LINK PROGRAMMABLE DIAGNOSTIC COMPUTER, BLOOD PRESSURE COMPUTER DQK BOSTON SCIENTIFIC CORPORATION H749555100R0 SPM04209 08714729939603

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown