BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM® ATHERECTOMY CATHETER

    MDR report key: 4950932 · Received July 29, 2015

    Report

    Report Number
    2134265-2015-05461
    Event Type
    Injury
    Date Received
    July 29, 2015
    Date of Event
    April 18, 2014
    Report Date
    June 30, 2015
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MCW
    PMA / PMN Number
    K130637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(6). IT WAS REPORTED THAT AN ISCHEMIC ULCER AND EXERTIONAL DYSPNEA OCCURRED. THE PATIENT WAS ENROLLED IN THE JET REGISTRY STUDY IN (B)(6) 2013. THE 6.0X10MM, 80% STENOSED, DE-NOVO TARGET LESION WAS LOCATED IN THE RIGHT FEMORAL SUPERFICIAL ARTERY (SFA). THE LESION WAS PRE-DILATED AND ATHERECTOMY WAS PERFORMED WITH THE JETSTREAM® NAVITUS SYSTEM. IN (B)(6) 2014, 170 DAYS POST INDEX PROCEDURE THE PATIENT DEVELOPED A RIGHT FOOT ISCHEMIC ULCER, AND EXERTIONAL DYSPNEA. TWO DAYS FOLLOWING THE PATIENT UNDERWENT AN UNPLANNED TARGET VESSEL RE-INTERVENTION (TVR) IN THE PREVIOUSLY TREATED SFA LESION. NO ADDITIONAL PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    493250 JETSTREAM® ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY MCW BOSTON SCIENTIFIC - MAPLE GROVE UNK875

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention