BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JETSTREAM XC ATHERECTOMY CATHETER

    MDR report key: 10368123 · Received August 5, 2020

    Report

    Report Number
    2134265-2020-10450
    Event Type
    Malfunction
    Date Received
    August 5, 2020
    Date of Event
    July 15, 2020
    Report Date
    September 3, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCW
    PMA / PMN Number
    K130637
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATED BY MFR: THE JETSTREAM DEVICE XC-2.1 WAS RECEIVED FOR ANALYSIS. THE SHAFT AND THE REMAINDER OF THE DEVICE WAS INSPECTED FOR DAMAGE. VISUAL EXAMINATION SHOWED A SEVERE KINK LOCATED 127.5CM FROM THE TIP. THE FUNCTIONALITY OF THE DEVICE WAS CHECKED BY SETTING UP THE PRODUCT PER THE INSTRUCTIONS FOR USE (IFU). THE DEVICE PRIMED AS INTENDED. THE DEVICE ACTIVATED AND THE BLADES DID SPIN AS INTENDED. THE BLADES WOULD THEN STOP AND START AGAIN PERIODICALLY. INSPECTION OF THE REMAINDER OF THE DEVICE, REVEALED NO DAMAGE OR IRREGULARITIES. DEVICE ANALYSIS DETERMINED THE CONDITION OF THE RETURNED DEVICE WAS CONSISTENT WITH THE REPORTED INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BLADES STOPPED SPINNING DURING USE. THE TARGET LESION WAS LOCATED IN THE POPLITEAL ARTERY. A 2.1MM JETSTREAM XC ATHERECTOMY CATHETER WAS SELECTED FOR USE. THE CATHETER WAS SUCCESSFULLY SET UP AND PRIMED NORMALLY. TWO RUNS WERE PERFORMED WITH BLADES UP THEN WITH BLADES DOWN. AFTER FOUR MINUTES OF USE WITHOUT ISSUE, THE REVS WERE SLOWING AND THE DEVICE STOPPED REXING. THE CATHETER ROTATION STOPPED IN FORWARD AND REX MODES WHILE CONSISTENTLY DEPRESSING THE BUTTON. THE CATHETER WAS REMOVED FROM THE PATIENT, RE-PRIMED ON THE TABLE AND TESTED IN FORWARD AND REX MODES WITH THE GUIDEWIRE IN THE GUARD; HOWEVER THE CATHETER WORKED INTERMITTENTLY WHILE THE FORWARD AND REX BUTTONS WERE PRESSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME CATHETER WITHOUT INCIDENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE BLADES STOPPED SPINNING DURING USE. THE TARGET LESION WAS LOCATED IN THE POPLITEAL ARTERY. A 2.1MM JETSTREAM XC ATHERECTOMY CATHETER WAS SELECTED FOR USE. THE CATHETER WAS SUCCESSFULLY SET UP AND PRIMED NORMALLY. TWO RUNS WERE PERFORMED WITH BLADES UP THEN WITH BLADES DOWN. AFTER FOUR MINUTES OF USE WITHOUT ISSUE, THE REVS WERE SLOWING AND THE DEVICE STOPPED REXING. THE CATHETER ROTATION STOPPED IN FORWARD AND REX MODES WHILE CONSISTENTLY DEPRESSING THE BUTTON. THE CATHETER WAS REMOVED FROM THE PATIENT, RE-PRIMED ON THE TABLE AND TESTED IN FORWARD AND REX MODES WITH THE GUIDEWIRE IN THE GUARD; HOWEVER THE CATHETER WORKED INTERMITTENTLY WHILE THE FORWARD AND REX BUTTONS WERE PRESSED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME CATHETER WITHOUT INCIDENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    834895 JETSTREAM XC ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY MCW BOSTON SCIENTIFIC CORPORATION 45007 0025228951

    Patients

    Seq Age Sex Outcome Treatment
    1