BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM® ATHERECTOMY CATHETER

    MDR report key: 5442365 · Received February 17, 2016

    Report

    Report Number
    2134265-2016-00761
    Event Type
    Injury
    Date Received
    February 17, 2016
    Date of Event
    January 29, 2013
    Report Date
    January 20, 2016
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    MCW
    PMA / PMN Number
    K130637
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: DEVICE NOT RETURNED THEREFORE ANALYSIS OF COMPLAINT DEVICE COULD NOT BE PERFORMED. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    (B)(4). IT WAS REPORTED THAT TARGET VESSEL REVASCULARIZATION OCCURRED. IN (B)(6) 2012, THE TARGET LESION WAS A DE NOVO LESION LOCATED IN THE LET SUPERFICIAL FEMORAL ARTERY(SFA) WITH A 100% STENOSIS AND WAS 10CM LONG WITH A REFERENCE VESSEL DIAMETER OF 5MM. THE TARGET LESION WAS TREATED WITH THE JETSTREAM NAVITUS SYSTEM. THE RESIDUAL STENOSIS PERCENTAGE WAS NOT PROVIDED. IN (B)(6) 2013, 70 DAYS POST-INDEX PROCEDURE, THE SUBJECT WAS HOSPITALIZED AND UNDERWENT PERIPHERAL INTERVENTIONAL REVASCULARIZATION DUE TO SEVERE CLAUDICATION OF THE LEFT LEG. SUCCESSFUL PERIPHERAL INTERVENTIONAL REVASCULARIZATION WAS PERFORMED OF THE ENTIRE LEFT SFA WITH ATHERECTOMY PLAQUE EXCISION USING A NON-BSC DEVICE, RESIDUAL STENOSIS WAS <10%. UNSUCCESSFUL PERIPHERAL INTERVENTIONAL REVASCULARIZATION WAS PERFORMED TO THE PROXIMAL LEFT ANTERIOR TIBIAL ARTERY INFLATING WITH 2X210MM NON-BSC BALLOON. STENOSIS REMAINED AT 100%. THE EVENT WAS CONSIDERED RESOLVED ON THE SAME DAY. THE SUBJECT WAS DISCHARGED THE FOLLOWING DAY ON CLOPIDOGREL. IN (B)(6) 2013, 161 DAYS POST INDEX PROCEDURE, THE SUBJECT UNDERWENT ANOTHER PERIPHERAL INTERVENTIONAL REVASCULARIZATION DUE TO LEFT LEG CLAUDICATION. SUCCESSFUL PERIPHERAL INTERVENTION WAS PERFORMED ON THE LESION WITH THE ENTIRE LEFT SFA, WITH ATHERECTOMY PLAQUE EXCISION USING A NON-BSC DEVICE AND INFLATING WITH A 6X100 NON-BSC BALLOON. RESIDUAL STENOSIS WAS <10%. THE EVENT RESOLVED ON THE SAME DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99115 JETSTREAM® ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY MCW BOSTON SCIENTIFIC - MAPLE GROVE UNK875

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention