BEUDAMED
    FDA Adverse Event Other Summary report: N

    JETSTREAM

    MDR report key: 3487775 · Received November 13, 2013

    Report

    Report Number
    2183460-2013-00014
    Event Type
    Other
    Date Received
    November 13, 2013
    Date of Event
    October 17, 2013
    Report Date
    November 12, 2013
    Manufacturer
    BAYER INTERVENTIONAL
    Product Code
    MCW
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT CONSISTS OF A JETSTREAM DEVICE GETTING STUCK ON A GUIDEWIRE RESULTING IN AN ALLEGED THROMBOSIS. THE PT IS A FEMALE OF UNK AGE AND A MEDICAL HISTORY OF SMOKING, DIABETES, AND PERIPHERAL ARTERY DISEASE (PAD). THE PT PRESENTED WITH A STENOSIS IN THE LEFT PROXIMAL SUPERFICIAL FEMORAL ARTERY (SFA) AND IN THE HUNTERS CANAL. THE PT HAD A TOTAL OF 8000 UNITS OF HEPARIN WITH AN ACTIVATED CLOTTING TIME (ACT) OF 235 SECONDS PRIOR TO THE PROCEDURE. THE PHYSICIAN DECIDED TO USE A JETSTREAM XC 2.4/3.4 ATHERECTOMY CATHETER THROUGH A 7FR INTRODUCER OVER AN UNK 0.014" GUIDEWIRE TO TREAT THE OCCLUSIONS. DURING THE JETSTREAM PROCEDURE THE JETSTREAM DEVICE WAS USED FOR 8 MINS WITH TWO PASSES WITH BLADES DOWN AND ONE ATTEMPT WITH BLADES OPEN. DURING THIS TIME, THE JETSTREAM DEVICE LOCKED UP AND COULD NOT BE REMOVED OVER THE GUIDEWIRE. THE JETSTREAM DEVICE AND GUIDEWIRE WERE REMOVED TOGETHER AND AN ANGIOGRAM WAS PERFORMED. IT WAS DETERMINED THAT THE SFA HAD THROMBOSED FROM THE ORIGIN OF THE SFA DOWN TO THE POPLITEAL. THE PHYSICIAN THEN USED AN ANGIOJET SOLENT OMNI THROMBECTOMY SET TO TREAT THE OCCLUSIONS FOLLOWED BY INFUSED LYTIC VIA ANGIOJET POWER PULSE WITH A DWELL TIME FOR 10 MINS. ANGIOJET THROMBECTOMY WAS AGAIN PERFORMED TO OPEN THE OCCLUSIONS. AN ANGIOGRAM WAS PERFORMED AND THE SFA WAS OPEN. THE PHYSICIAN DEPLOYED A 5 MM COVERED STENT AT THE ORIGIN OF THE ADDUCTOR CANAL AND A 5 MM SELF-EXPANDING STENT IN THE PROXIMAL SFA. IN THIS CASE THE MFR OF THE 0.014" GUIDEWIRE IS UNK THUS WE CANNOT DETERMINE IF IT WAS A RECOMMENDED COMPATIBLE GUIDEWIRE WITH THE JETSTREAM SYSTEM. THIS COMMITTEE DETERMINED THAT THIS EVENT IS REPORTABLE SINCE THE PT REQUIRED INTERVENTION TO REMOVE THE ALLEGED OCCLUSION FROM THE ORIGIN OF THE SFA DOWN TO THE POPLITEAL AND THE ASSOCIATION BETWEEN THE STICKING OF THE JETSTREAM XC 2.4/3.4 DEVICE ON THE GUIDEWIRE AND NOTED EVENT CANNOT BE CONCLUSIVELY RULED OUT.

    Description of Event or Problem · 1

    DIABETIC, SMOKER, PAD. PT HAD STENOSIS IN THE LEFT PROXIMAL SFA, AND IN THE HUNTERS CANAL. DEVICE LOCKED UP, AND COULD NOT BE REMOVED OVER THE WIRE ONCE WIRE AND JETSTREAM DEVICE WAS REMOVED, AN ANGIOGRAM WAS PERFORMED, AND IT WAS DETERMINED THAT THE SFA HAD THROMBOSED FROM THE ORIGIN OF THE SFA DOWN THE POPLITEAL. ANGIOJET WAS THEN USED (SOLENT OMNI) THROMBECTOMY FIRST WITH SUBSEQUENT POWER PULSE. INFUSED LYTIC AGENT PER PHYSICIANS SPECIFICATIONS AND ALLOWED TO DWELL FOR 10 MINS. ANGIOJET THROMBECTOMY WAS PERFORMED TO OPEN OCCLUSION. ANGIOGRAM PERFORMED, SFA WAS OPEN. PHYSICIAN DEPLOYED A 5 MM COVERED STENT AT THE ORIGIN OF THE ADDUCTOR CANAL, AND A 5 MM SELF EXPANDING STENT IN THE PROXIMAL SFA. UPDATE PROVIDED BY (B)(4), SALES REP ON (B)(4) 2013: PT HAD A TOTAL OF 8000 OF HEPARIN ON BOARD 235 ACT, 8 MIN RUN TIME. PT THROMBOSED AFTER JETSTREAM WAS USED WITH WINGS OPEN. TWO PASSES WITH WING DOWN, AND ONE ATTEMPT WITH WINGS OPEN. SUBSEQUENT ANGIOGRAM SHOW THAT THE SFA HAD CLOSED DUE TO THROMBUS. ANGIOJET RESOLVED THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    587952 JETSTREAM JETSTREAM XC 2.4MM CATHETER MCW BAYER INTERVENTIONAL 156595

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention