BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMET II

    MDR report key: 15698720 · Received October 31, 2022

    Report

    Report Number
    2124215-2022-43177
    Event Type
    Malfunction
    Date Received
    October 31, 2022
    Date of Event
    October 11, 2022
    Report Date
    November 8, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. RETURNED PRODUCT CONSISTED OF AN FFR COMET PRESSURE WIRE. THE OCC CABLE WAS NOT RETURNED FOR ANALYSIS. THE OCC CABLE, TIP, AND DEVICE SHAFT WERE VISUALLY AND MICROSCOPICALLY EXAMINED FOR DAMAGE OR ANY IRREGULARITIES. INSPECTION OF THE DEVICE REVEALED THAT THE TIP WAS STRETCHED AND PARTIALLY DETACHED AT THE PROXIMAL END WHERE IT MEETS THE SENSOR HOUSING. THE APPEARANCE OF THE CONFIRMED TIP DAMAGE IS CONSISTENT TO DAMAGE THAT CAN BE CAUSED FROM INTERACTION WITH HANDLING THE DEVICE DURING UNPACKAGING OR PREPARATION OR CAN BE CAUSED FROM INTERACTION WITH ANOTHER DEVICE OR PATIENT ANATOMY DURING THE PROCEDURE. AS THE OCC CABLE WAS NOT RETURNED FOR ANALYSIS, A TEST OCC CABLE WAS USED FOR DEVICE-TO-DEVICE TESTING. THE PROXIMAL END OF THE WIRE WAS INSERTED INTO THE HANDLE OF THE OCC CABLE. THE SHROUD OF THE OCC CABLE WAS THEN CONNECTED TO THE FFR LINK TO VERIFY THE SIGNAL STRENGTH. THE SIGNAL WAS PRESENT AND THE "SIGNAL STRENGTH" AND "ZEROED" SHOWED GREEN LIGHTS, AS DESIGNED. THE OCC CABLE WAS THEN CONNECTED TO THE BENCH TOP TESTING EQUIPMENT. THE MODULATION WAS 14.3% AND THE COEFFICIENT VALUES WERE CONFIRMED TO BE PROGRAMMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DISTAL TIP FRACTURE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE LEFT RADIAL ARTERY. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A COMET II PRESSURE GUIDEWIRE WAS USED IN A CORONARY ANGIOGRAM PROCEDURE. UPON UNPACKING, THE COMET II WAS NOTED TO BE DEFORMED AND WAS FELT THAT IT WAS ALREADY BROKEN. HOWEVER, SINCE THERE WAS NO EXTERNAL DAMAGE, THE COMET II WAS CONTINUED TO BE USED AND EQUALIZED IN THE BODY OF THE PATIENT. DURING THE WIRING OF THE LESION THE COMET II FRACTURED BUT REMAINED IN ONE PIECE. THE COMET II WAS REMOVED WITHOUT ANY RESIDUE LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DISTAL TIP FRACTURE OCCURRED.VASCULAR ACCESS WAS OBTAINED VIA THE LEFT RADIAL ARTERY. THE 75% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MILDLY CALCIFIED CORONARY ARTERY. A COMET II PRESSURE GUIDEWIRE WAS USED IN A CORONARY ANGIOGRAM PROCEDURE. UPON UNPACKING, THE COMET II WAS NOTED TO BE DEFORMED AND WAS FELT THAT IT WAS ALREADY BROKEN. HOWEVER, SINCE THERE WAS NO EXTERNAL DAMAGE, THE COMET II WAS CONTINUED TO BE USED AND EQUALIZED IN THE BODY OF THE PATIENT. DURING THE WIRING OF THE LESION THE COMET II FRACTURED BUT REMAINED IN ONE PIECE. THE COMET II WAS REMOVED WITHOUT ANY RESIDUE LEFT IN THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2649478 COMET II TRANSDUCER, PRESSURE, CATHETER TIP DXO BOSTON SCIENTIFIC CORPORATION 2404-03 0029554696

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown