BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JETSTREAM® ATHERECTOMY CATHETER

    MDR report key: 5440630 · Received February 17, 2016

    Report

    Report Number
    2134265-2016-00705
    Event Type
    Injury
    Date Received
    February 17, 2016
    Date of Event
    May 8, 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
    LA, 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)(6). IT WAS REPORTED THAT DISTAL EMBOLIZATION OCCURRED, POST TREATMENT PROCEDURE THE PATIENT EXPERIENCED TARGET VESSEL REVASCULARIZATION AND BELOW THE KNEE AMPUTATION. IN (B)(6) 2013, THE 80% STENOSED, 20CM IN LENGTH DE NOVO TARGET LESION WAS LOCATED IN THE LEFT SUPERFICIAL FEMORAL ARTERY (SFA) WITH A REFERENCE DIAMETER OF 6MM. TARGET LESION WAS TREATED WITH A JETSTREAMTHERECTOMY CATHETER. THERE WAS ONE BLADES DOWN PASS FOR 1 MIN 20 SEC, AND ONE BLADES-UP PASS FOR 1 MIN 51 SEC, WITH A TOTAL RUN TIME OF 3 MIN 10 SEC. 350 CC ASPIRANT WAS COLLECTED. POST-JETSTREAM TREATMENT STENOSIS WAS 20%. THE TARGET LESION WAS ALSO TREATED WITH ADJUNCTIVE THERAPY PTA AND A FETCH ASPIRATION CATHETER. POST-ADJUNCTIVE THERAPY STENOSIS WAS 10%. DURING THE INDEX PROCEDURE, A DISTAL EMBOLIZATION OCCURRED. TLR CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY IN STABLE CONDITION. IN (B)(6) 2013, 56 DAYS POST-INDEX PROCEDURE THE SUBJECT UNDERWENT A TARGET LESION REVASCULARIZATION (TLR). ACCESS WAS GAINED VIA THE RIGHT FEMORAL ARTERY. A 0.14 WIRE WAS INSERTED DOWN THE LEFT POSTERIOR TIBIAL ARTERY FOLLOWED BY A 0.018 AND 0.014 SUPPORT CATHETERS, BUT WERE UNABLE TO CROSS INTO THE DISTAL VESSEL. DILATION WAS PERFORMED WITH A 2X80 NON-BSC BALLOON THROUGHOUT MUCH OF THE LEFT POSTERIOR TIBIAL ARTERY BUT GOOD DISTAL FLOW WAS NOT ACHIEVED. THE WIRE WAS PLACED DOWN THE ANTERIOR TIBIAL ARTERY AND DILATION WAS PERFORMED WITH A 2X80 NON-BSC BALLOON. MULTIPLE TECHNIQUES WERE TRIED TO CROSS THE DISTAL STENOSIS BUT WERE UNSUCCESSFUL. A 1.5X80 NON-BSC BALLOON WAS SUCCESSFUL AT CROSSING AND DILATION WAS PERFORMED. FINAL SHOTS SHOWED A STRAIGHT LINE FLOW THROUGH THE ANTERIOR TIBIAL ARTERY BUT SOME SLUGGISH FLOW AGAIN THROUGH THE POSTERIOR TIBIAL ARTERY. TLR CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. IN (B)(6) 2013, 98 DAYS POST-INDEX PROCEDURE THE SUBJECT UNDERWENT A TARGET LESION REVASCULARIZATION (TLR) BELOW THE KNEE. TLR OF THE LEFT ANTERIOR TIBIAL ARTERY WAS PERFORMED AND CONSIDERED RESOLVED ON THE SAME DAY. IN (B)(6) 2013, 128 DAYS POST-INDEX PROCEDURE THE SUBJECT UNDERWENT AMPUTATION OF HIS LEFT LEG BELOW THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97798 JETSTREAM® ATHERECTOMY CATHETER CATHETER, PERIPHERAL, ATHERECTOMY MCW BOSTON SCIENTIFIC - MAPLE GROVE UNK875

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention