BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMET

    MDR report key: 9410986 · Received December 4, 2019

    Report

    Report Number
    2134265-2019-14806
    Event Type
    Malfunction
    Date Received
    December 4, 2019
    Date of Event
    October 4, 2019
    Report Date
    December 4, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DXO
    UDI-DI
    08714729904397
    PMA / PMN Number
    K151610
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RETURNED PRODUCT CONSISTED OF AN FFR COMET PRESSURE WIRE CONNECTED TO THE OCC CABLE. THE TIP, DEVICE SHAFT, SENSOR PORT AND THE COEFFICIENT VALUES WERE EXAMINED FOR DAMAGE OR ANY IRREGULARITIES. THE SHAFT SHOWED 2 KINKS. THE KINKS WERE LOCATED AT 32.5CM AND 38CM FROM THE TIP. THE TIP SHOWED BEND DAMAGE. THERE WAS COATING PEELED AT THE 32.5CM LOCATION. 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 THE FEP DISK FOR DAMAGE. IT WAS NOTICED THAT THE FEP DISK WAS DAMAGED WHERE THE WIRE SEATS AGAINST THE DISK. 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 COEFFICIENT WAS CONFIRMED TO BE IN SPECIFICATION. BECAUSE THERE WAS NO EVIDENCE OF ANY PRODUCT QUALITY DEFICIENCIES, IT WAS CONSIDERED LIKELY THAT THE SHAFT DAMAGE, TIP DAMAGE AND THE PEELED COATING DAMAGE WERE ATTRIBUTABLE TO HANDLING ISSUES.

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS COMPLETED ON 18NOV2019. DURING A CORONARY ANGIOGRAM, A COMET PRESSURE GUIDEWIRE WAS SELECTED TO PERFORM A FRACTIONAL FLOW RESERVE STUDY. THE COMET PRESSURE GUIDEWIRE WAS PREPARED AS PER THE DFU AND CONNECTED TO THE FFR LINK; HOWEVER, THE COMET PRESSURE GUIDEWIRE FAILED TO ZERO. THE COMET WAS DISCONNECTED AND REATTACHED A NUMBER OF TIMES; HOWEVER, THE RESULT WAS THE SAME. ANOTHER COMET PRESSURE GUIDEWIRE WAS OPENED AND USED WITHOUT ANY ISSUE. HOWEVER, RETURNED DEVICE ANALYSIS REVEALED PEELED COATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1205634 COMET TRANSDUCER, PRESSURE, CATHETER TIP DXO BOSTON SCIENTIFIC CORPORATION 8900 0022948336 08714729904397

    Patients

    Seq Age Sex Outcome Treatment
    1