BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMET

    MDR report key: 8313125 · Received February 6, 2019

    Report

    Report Number
    2134265-2019-00730
    Event Type
    Malfunction
    Date Received
    February 6, 2019
    Date of Event
    December 5, 2018
    Report Date
    February 6, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXO
    UDI-DI
    08714729904397
    PMA / PMN Number
    K151610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT CONSISTED OF A FFR COMET PRESSURE WIRE CONNECTED TO THE RFID CABLE. THE TIP, DEVICE SHAFT, SENSOR PORT AND THE COEFFICIENT VALUES WAS EXAMINED FOR DAMAGE OR ANY IRREGULARITIES. THE DEVICE SHOWED 3 KINKS LOCATED AT 55.2CM, 92.5CM, AND 180CM FROM THE TIP. THE TIP SHOWED STRETCHED COILS. THERE WAS PEELED COATING AT THE 55.2CM KINK. THE COMET WIRE WAS CONNECTED TO THE FFR LINK FOR SIGNAL VERIFICATION. THE SIGNAL WAS PRESENT AS DESIGNED. THE OCB CONNECTOR CABLE WAS LOOSENED 1 TURN TO REMOVE THE WIRE FROM THE HANDLE. THE WIRE WOULD NOT EXIT THE COLLET OR HANDLE. THE TURN KNOB WAS LOOSENED AND TAKEN OFF THE OCB HANDLE. THE COLLET WAS STUCK IN THE CAP. THE COLLET WAS GENTLY MOVED BACK AND FORTH UNTIL THE COLLECT CAME LOOSE FROM THE CAP. THE INSIDE OF THE CAP WAS INSPECTED AND FOUND THAT THERE WAS DAMAGE. THE COLLET WAS JAMMED IN AND STUCK IN THE CAP WHICH CAUSED THE COLLET NOT TO LET GO OF THE WIRE. IT IS POSSIBLE DURING THE ASSEMBLY PROCESS OF THE OCB HANDLE THAT THE WIRE WAS INSERTED INTO THE COLLET AND AS THE CAP WAS TIGHTENED AND THE COLLET BECAME SKEWED AND JAMMED IN THE CAP. 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. THE PRESSURE WIRE WAS CONNECTED TO THE ANALYSIS SUPPORT TEST BENCH AND ALL APPLICABLE DATA WAS CORRECT AS DESIGNED, THERE WAS NO DIFFICULTY IN CONNECTING THE WIRE. THE COEFFICIENT VALUES WERE CONFIRMED TO BE IN SPECIFICATION. THE COMPLAINT OF AN UNLOCKING ISSUE WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FAILURE TO UNLOCK THE HANDLE OCCURRED. A COMET GUIDEWIRE WAS USED DURING AN FFR PROCEDURE. DURING THE PROCEDURE, WHILE INSIDE THE PATIENT, THE WIRE COULD NOT BE DISCONNECTED FROM THE HANDLE (TORQUER). A LOT OF FORCE WAS USED TO REMOVE THE WIRE AND RESULTED IN KINKS IN THE WIRE. ONCE THE WIRE WAS DISCONNECTED, IT WAS POSSIBLE TO CONNECT AND DISCONNECT AS USUAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. HOWEVER, DEVICE ANALYSIS REVEALED PEELED COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    102254 COMET TRANSDUCER, PRESSURE, CATHETER TIP DXO BOSTON SCIENTIFIC CORPORATION 8900 0022700789 08714729904397

    Patients

    Seq Age Sex Outcome Treatment
    1