BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMET

    MDR report key: 10476472 · Received September 1, 2020

    Report

    Report Number
    2134265-2020-11370
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Date of Event
    June 24, 2020
    Report Date
    September 1, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXO
    UDI-DI
    08714729904403
    PMA / PMN Number
    K151610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. RETURNED PRODUCT CONSISTED OF AN FFR COMET PRESSURE WIRE CONNECTED TO THE OCC CABLE. THE TIP, DEVICE SHAFT, SENSOR PORT AND THE COEFFICIENT VALUES WERE EXAMINED FOR DAMAGE OR ANY IRREGULARITIES. THE SHAFT SHOWED 2 KINKS LOCATED 175.5CM FROM THE TIP AND AT THE OCC HANDLE. THERE WAS PEELED COATING AT THE 175.5CM LOCATION. THE OCC HANDLE WAS CONNECTED TO THE FFR LINK TO VERIFY THE SIGNAL STRENGTH. THE SIGNAL WAS PRESENT AND SHOWED GREEN LIGHTS AS DESIGNED. THE WIRE WAS INSERTED INTO THE PRESSURE CHAMBER TEST EQUIPMENT AND THE PRESSURE WAS INCREASED TO VERIFY THE SENSOR WAS INDEED REACTING TO THE PRESSURE INCREASES AND DECREASES. THE PRESSURE SENSOR FUNCTIONED AS DESIGNED. THE COEFFICIENT WAS CONFIRMED TO BE PROGRAMMED PER DOCUMENT. THE OCC HANDLE WAS AGAIN CONNECTED TO THE FFR LINK. THE DEVICE WAS THEN CONNECTED TO THE POLARIS (ILAB) TEST EQUIPMENT VIA BLUETOOTH SIGNAL. THE FFR LINK AND WIRE COMMUNICATED TO THE POLARIS SYSTEM AND ZEROED AS DESIGNED. WITH THE WIRE INSERTED INTO THE TEST PRESSURE CHAMBER, THE WIRE TRANSFERRED A PD PRESSURE WAVEFORM TO THE POLARIS WHICH INDICATES A FUNCTIONING WIRE. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES. THE OCC HANDLE CAP WAS LOOSENED TO REMOVE THE WIRE. THERE WAS NO ISSUE WITH REMOVING THE WIRE. THE SENSOR HOUSING SHOWED NO RESIDUE OF BODY FLUIDS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WIRE KINK OCCURRED. WHEN THE COMET PRESSURE GUIDEWIRE WAS INSERTED INTO THE PATIENT, THE WIRE KINKED AT THE BASE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE WITH NO PATIENT INJURY. HOWEVER, DEVICE ANALYSIS REVEALED PEELED COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942771 COMET TRANSDUCER, PRESSURE, CATHETER TIP DXO BOSTON SCIENTIFIC CORPORATION 8900 0025064010 08714729904403

    Patients

    Seq Age Sex Outcome Treatment
    1