BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMET

    MDR report key: 9378721 · Received November 26, 2019

    Report

    Report Number
    2134265-2019-14052
    Event Type
    Malfunction
    Date Received
    November 26, 2019
    Date of Event
    September 21, 2019
    Report Date
    November 26, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXO
    UDI-DI
    08714729904397
    PMA / PMN Number
    K151610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED TO MANUFACTURER: THE COMET WAS RETURNED AND ANALYSIS WAS COMPLETED. THE TIP, DEVICE SHAFT, SENSOR PORT AND THE COEFFICIENT VALUES WERE EXAMINED FOR DAMAGE OR ANY IRREGULARITIES. THE SHAFT SHOWED TWO KINKS. THE FIRST KINK WAS LOCATED 38CM FROM THE TIP. THE SECOND KINK WAS LOCATED 177CM FROM THE TIP. THERE WAS TIP DAMAGE NOTICED. THERE WAS PEELED COATING AT THE 177CM LOCATION. THE WIRE WAS CONNECTED TO THE RETURNED OCC HANDLE. THE OCC HANDLE WAS CONNECTED TO THE FFR LINK FOR SIGNAL VERIFICATION. THE SIGNAL WAS NOT PRESENT AS DESIGNED. THE OCC HANDLE CAP WAS LOOSENED TO REMOVE THE WIRE. THERE WAS NO ISSUE WITH REMOVING THE WIRE. A KNOWN GOOD OCC HANDLE WAS USED TO VERIFY CABLE OPERATION WAS CORRECT WITH THE RETURNED OCC. THE TEST OCC CABLE AND THE CONNECTED RETURNED WIRE FUNCTIONED AS DESIGNED. THE RETURNED CABLE WAS DISSECTED TO CHECK FOR DAMAGE. IT WAS NOTICED THAT THE FEP DISK WAS DAMAGED WHERE THE WIRE SEATS AGAINST THE DISK. INSPECTION OF THE REMAINDER OF THE DEVICE, APART FROM THE OBSERVED DAMAGE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES.

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED 14 NOV 2019. IT WAS REPORTED THAT THE COMET PRESSURE HAD BEEN UNABLE TO BE RECOGNIZED BY THE FFR LINK. ANOTHER COMET WAS USED TO COMPLETE THE PROCEDURE WITHOUT ISSUE. HOWEVER, THE RETURNED DEVICE ANALYSIS REVEALED SOME SLIGHT PEELING OF THE DEVICE COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1172036 COMET TRANSDUCER, PRESSURE, CATHETER TIP DXO BOSTON SCIENTIFIC CORPORATION 8900 0023099681 08714729904397

    Patients

    Seq Age Sex Outcome Treatment
    1