BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMET

    MDR report key: 10013265 · Received April 30, 2020

    Report

    Report Number
    2134265-2020-05822
    Event Type
    Malfunction
    Date Received
    April 30, 2020
    Date of Event
    April 7, 2020
    Report Date
    June 11, 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

    B5: CORRECTED EVENT DESCRIPTION E1: STATE: YAMAGUCHI PERFECTURE DEVICE EVALUATED BY MFR: THE PRODUCT WAS RETURNED TO BOSTON SCIENTIFIC FOR ANALYSIS. RETURNED PRODUCT CONSISTED OF AN OCC HANDLE ONLY, THE WIRE WAS NOT RETURNED. SINCE THE GUIDEWIRE WAS NOT RETURNED, THIS ANALYSIS WAS CONDUCTED ON THE OCC HANDLE ONLY. THE COLLET AND CAP WERE NOT RETURNED ON THE RETURNED THE OCC HANDLE. A .014 TEST COMET PRESSURE WIRE WAS USED TO TEST THE FUNCTIONALITY OF THE OCC HANDLE. A COLLET AND CAP FROM A TEST OCC HANDLE WERE USED ON THE RETURNED OCC HANDLE. THE WIRE WAS INSERTED INTO THE OCC HANDLE AND CONNECTED TO THE FFR LINK. THE WIRE SHOWED A SIGNAL WITH GREEN LIGHTS. THE COEFFICIENT VALUES WERE CONFIRMED TO BE PROGRAMMED. 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 WITH NO ISSUES. INSPECTION OF THE REMAINDER OF THE DEVICE REVEALED NO DAMAGE OR IRREGULARITIES. THE ANALYSIS WITH THE TEST COMPONENTS DID NOT SHOW ANY ABNORMALITIES WHEN TESTING THE DEVICE. SINCE THE ORIGINAL COMPONENTS OF THE DEVICE WERE NOT RETURNED THE COMPLAINT WAS NOT CONFIRMED FOR DETACHMENT OF THE WIRE AND OCC HANDLE MALFUNCTIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A GUIDEWIRE BREAK OCCURRED. DURING PREPARATION, OUTSIDE THE PATIENT, AND WHILE REMOVING A COMET PRESSURE GUIDEWIRE FROM THE FREE SPIN HANDLE, IT WAS NOTICED THAT THE WIRE HAD BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. IT WAS FURTHER REPORTED THAT WHILE DISCONNECTING THE WIRE FROM THE OCC HANDLE, THE CAP PART OF THE OCC HANDLE BECAME DETACHED. THE HANDLE WAS REMOVED TOGETHER WITH THE WIRE. AFTER DISCONNECTING THE WIRE FROM THE HANDLE, THE WIRE WAS NOT ABLE TO RECONNECT TO THE HANDLE. NO DAMAGE WAS NOTED IN THE WIRE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GUIDEWIRE BREAK OCCURRED. DURING PREPARATION, OUTSIDE THE PATIENT, AND WHILE REMOVING A COMET PRESSURE GUIDEWIRE FROM THE FREE SPIN HANDLE, IT WAS NOTICED THAT THE WIRE HAD BROKEN. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478927 COMET TRANSDUCER, PRESSURE, CATHETER TIP DXO BOSTON SCIENTIFIC CORPORATION 8900 0025016401 08714729904403

    Patients

    Seq Age Sex Outcome Treatment
    1