BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMET

    MDR report key: 10185167 · Received June 23, 2020

    Report

    Report Number
    2134265-2020-08354
    Event Type
    Malfunction
    Date Received
    June 23, 2020
    Date of Event
    May 25, 2020
    Report Date
    August 19, 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
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. THE TIP, DEVICE SHAFT AND SENSOR PORT WERE EXAMINED FOR DAMAGE OR ANY IRREGULARITIES. THE WIRE SHAFT SHOWED A KINK AT THE PROXIMAL END OF THE WIRE WHERE THE WIRE CONNECTS TO THE OCC HANDLE. THERE WAS A KINK LOCATED AT 38CM FROM THE TIP. THE TIP SHOWED BEND DAMAGE AND STRETCHED COILS. SINCE NO OCC HANDLE WAS RECEIVED FOR ANALYSIS, A TEST OCC HANDLE WAS USED FOR FUNCTIONALITY OF THE WIRE. THE WIRE WAS CONNECTED TO THE TEST OCC HANDLE. 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 OCC HANDLE WAS THEN CONNECTED TO THE BENCH TOP TESTING EQUIPMENT AND THE WIRE WAS INSERTED INTO THE PRESSURE CHAMBER. 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 VALUES COULD NOT BE VERIFIED DUE TO THE OCC HANDLE NOT BEING RETURNED. 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 WIRE COMMUNICATED TO THE POLARIS SYSTEM AND ZEROED AS DESIGNED. WITH THE WIRE INSERTED INTO THE TEST PRESSURE CHAMBER, THE WIRE TRANSFERRED A PRESSURE WAVEFORM TO THE POLARIS WHICH INDICATES A FUNCTIONING WIRE. THE WIRE WAS REMOVED FROM THE OCC HANDLE. THE SENSOR PORT SHOWED NO RESIDUE OF BODY FLUIDS. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE COMET GEN 1 PRESSURE GUIDEWIRE WAS DIFFICULT TO REMOVE. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY TO MID LAD. THIS COMET GEN 1 PRESSURE GUIDEWIRE WAS SELECTED FOR USE DURING THIS CORONARY ANGIOGRAPHY PROCEDURE. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT INTO THE CORONARY ARTERY, HOWEVER DURING REMOVAL ABNORMAL RESISTANCE WAS FELT. A VISUAL CHECK WAS PERFORMED OUTSIDE THE BODY AND THERE WERE NO KINKS FOUND. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT INJURY DUE TO DIFFICULTY REMOVING THE GUIDEWIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE COMET GEN 1 PRESSURE GUIDEWIRE WAS DIFFICULT TO REMOVE. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MILDLY TORTUOUS LEFT ANTERIOR DESCENDING (LAD) ARTERY TO MID LAD. THIS COMET GEN 1 PRESSURE GUIDEWIRE WAS SELECTED FOR USE DURING THIS CORONARY ANGIOGRAPHY PROCEDURE. THERE WAS NO RESISTANCE FELT DURING ADVANCEMENT INTO THE CORONARY ARTERY, HOWEVER DURING REMOVAL ABNORMAL RESISTANCE WAS FELT. A VISUAL CHECK WAS PERFORMED OUTSIDE THE BODY AND THERE WERE NO KINKS FOUND. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT INJURY DUE TO DIFFICULTY REMOVING THE GUIDEWIRE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647012 COMET TRANSDUCER, PRESSURE, CATHETER TIP DXO BOSTON SCIENTIFIC CORPORATION 8900 0024922237 08714729904403

    Patients

    Seq Age Sex Outcome Treatment
    1