BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM XC ATHERECTOMY CATHETER

    MDR report key: 8401805 · Received March 7, 2019

    Report

    Report Number
    2134265-2019-02142
    Event Type
    Injury
    Date Received
    March 7, 2019
    Date of Event
    October 25, 2018
    Report Date
    March 7, 2019
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MCW
    PMA / PMN Number
    K130637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A GRADE C DISSECTION. THE 99% STENOSED, 3.0MMX27MM, TASC II B TARGET CLASSIFIED LESION WAS LOCATED IN THE RIGHT DISTAL SUPERFICIAL FEMORAL ARTERY. THE LESION WAS TREATED WITH A 2.1 MM JETSTREAM XC ATHERECTOMY CATHETER. POST TREATMENT, PERCUTANEOUS TRANSLUMINAL BALLOON ANGIOPLASTY (PTA) WAS PERFORMED, WITH 1% FINAL RESIDUAL STENOSIS. IT WAS NOTED THAT THERE WAS EVIDENCE OF A GRADE C DISSECTION OF 11.0 MM LENGTH IN THE LOCATION 'IN SEG' AND DISTAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194477 JETSTREAM XC ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY MCW BOSTON SCIENTIFIC CORPORATION 45007 0021394586

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Other