BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM

    MDR report key: 3093526 · Received May 6, 2013

    Report

    Report Number
    2183870-2013-00107
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    February 28, 2013
    Report Date
    April 10, 2013
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE COULD NOT BE REVIEWED BECAUSE THE CORRECT LOT NUMBER WAS NOT PROVIDED. PROCEDURE REPORT RECEIVED.

    Description of Event or Problem · 1

    THE TURBOHAWK DEVICE WAS ADVANCED AND DEPLOYED INTO THE POPLITEAL STENOSIS MAKING TWO CUTS AT 180 DEGREES FROM EACH OTHER. IT WAS THEN BROUGHT ACROSS THE OCCLUDED PROXIMAL POSTERIOR TIBIAL ARTERY AND DEPLOYED WITH ONE CUT DOWN TO ABOUT MIDWAY DOWN THE CALF. THE DEVICE WAS THEN WITHDRAWN AND A SHEATH SHOT SHOWED IMPROVEMENT IN THE POPLITEAL LESION BUT THERE WAS EXTRAVASATION/FISTULIZATION AT THE POSTERIOR TIBIAL SITE. A 2.0MM BALLOON WAS BROUGHT ACROSS THE AREA OF EXTRAVASATION AND LEFT BEHIND FOR 2 THREE MINUTE INTERVALS. THIS DID NOT RESOLVE THE EXTRAVASATION BUT EACH INJECTION DID RESULT IN FAIRLY RAPID CLEARANCE OF CONTRAST INDICATING THIS WAS A FISTULA INTO AN ADJACENT VEIN RATHER THAN FREE EXTRAVASATION INTO THE TISSUE. THE PATIENT WAS ALSO MINIMALLY SYMPTOMATIC WITH ONLY MILD TENDERNESS AT THE SITE OF EXTRAVASATION. THE WIRE WAS LEFT IN PLACE AND THE ANTERIOR TIBIAL WAS ADDRESSED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197273 TURBOHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. THS-SX-C UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention NITREX GUIDEWIRE| VIANCE CROSSING CATHETER| NANOCROSS BALLOON