BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JETSTREAM XC ATHERECTOMY CATHETER

    MDR report key: 8144223 · Received December 7, 2018

    Report

    Report Number
    2134265-2018-63445
    Event Type
    Malfunction
    Date Received
    December 7, 2018
    Date of Event
    November 12, 2018
    Report Date
    December 7, 2018
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCW
    PMA / PMN Number
    K130637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). AGE AT TIME OF EVENT: 18 YEARS OR OLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BLACK SHEDDING WAS OBSERVED UPON LOADING THE DEVICE OVER THE GUIDEWIRE. A 2.4MM JETSTREAM XC ATHERECTOMY CATHETER AND A NON-BSC GUIDEWIRE WERE SELECTED FOR USE IN AN ATHERECTOMY PROCEDURE IN THE SUPERFICIAL FEMORAL VEIN (SFV). DURING PREPARATION, THE JETSTREAM DEVICE WAS BEING LOADED OVER THE GUIDEWIRE WHEN IT WAS NOTED THAT THE OUTER LAYER HAS BLACK SHEDDING IN THE FRONT OF THE CATHETER NEAR THE DRILL BIT. A JESTREAM XC CATHETER WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AND THE PATIENT'S STATUS IS STABLE. DEVICE EVALUATED BY MFG: THE DEVICE AND THE CATHETER SHAFT WERE CHECKED FOR DAMAGE. THE DEVICE SHOWED NO DAMAGE. VISUAL AND MICROSCOPIC ANALYSIS WAS COMPLETED AND NO OUTER LAYER ISSUES WERE NOTICED ON THE SHAFT. PRODUCT ANALYSIS TESTED THE DEVICE AND THE DEVICE FUNCTIONED AS DESIGNED WITH NO ISSUES OR ERRORS. INSPECTION OF THE REMAINDER OF THE DEVICE, REVEALED NO OTHER DAMAGE OR IRREGULARITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    980716 JETSTREAM XC ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY MCW BOSTON SCIENTIFIC CORPORATION 45007 0022256573

    Patients

    Seq Age Sex Outcome Treatment
    1