BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM

    MDR report key: 3023969 · Received March 27, 2013

    Report

    Report Number
    2183870-2013-00069
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    January 29, 2013
    Report Date
    March 19, 2013
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT, HOWEVER, A 7F SHEATH WAS USED IN THIS PROCEDURE AND THE PRODUCT IS RECOMMENDED FOR AN 8F SHEATH. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE PROCEDURE WAS A LEFT SFA INTERVENTION VIA RIGHT FEMORAL ACCESS. THE SITE THOUGHT THE TURBOHAWK SOUNDED FUNNY WHEN PREPPING BUT DID NOT NOTICE ANY SEPARATION. AFTER 3-4 INSERTIONS WERE MADE IT WAS NOTED THAT THE DEVICE SEEMED TO BE STICKING. ON LAST INSERTION A SEPARATION OF THE TIP WAS NOTED. EVALUATION OF THE RETURNED PRODUCT FOUND THE TIP WAS SEPARATED AND ONE OF THE PINS FROM THE HOUSING COMPONENT WAS MISSING. THE LOCATION OF THE PIN IS UNKNOWN, HOWEVER NO EMBOLIZATION OR INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126244 TURBOHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. THS-LX-C 9631202

    Patients

    Seq Age Sex Outcome Treatment
    1 Other 7F RAABE SHEATH| 5.0 SPIDERFX