BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK¿ PLAQUE EXCISION SYSTEM

    MDR report key: 2090272 · Received May 16, 2011

    Report

    Report Number
    2183870-2011-00100
    Event Type
    Injury
    Date Received
    May 16, 2011
    Date of Event
    March 9, 2011
    Report Date
    April 20, 2011
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    THIS PROCEDURE OCCURRED IN (B)(6): A LONG AT CALCIFIED OCCLUSION (10CM) WAS TREATED WITH THE TURBOHAWK. THE DISTAL AT WAS NOT AS CALCIFIED AS THE PROXIMAL SEGMENT. ONE PASS WAS PERFORMED AT THE DISTAL PORTION OF THE VESSEL. A SMALL PERFORATION RESULTED IN AN AV FISTULA AT THE LEVEL OF THE ANKLE. THE AV FISTULA WAS RESOLVED AFTER BALLOON INFLATION THAT LASTED 2 MINUTES. THE RESULTS OF THE PROCEDURE WAS GOOD. THE DISTAL FLOW WAS IMPROVED AFTER THE TREATMENT WITH THE TURBOHAWK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBOHAWK¿ PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. THS-SX-C 9412338

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention TERUMO 6F SHEATH| TRAILBLAZER SUPPORT CATHETER