BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK ® PLAQUE EXCISION SYSTEM

    MDR report key: 2880077 · Received December 19, 2012

    Report

    Report Number
    2183870-2012-00240
    Event Type
    Injury
    Date Received
    December 19, 2012
    Date of Event
    September 10, 2012
    Report Date
    December 6, 2012
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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.

    Description of Event or Problem · 1

    THIS PROCEDURE WAS PERFORMED IN (B)(6) AND IS PART OF (B)(6). THE PROCEDURE DATE WAS (B)(6) 2012. A DISTAL EMBOLISM (PLAQUE, THROMBUS, OR DEBRIS) WAS REPORTED. PTA WAS PERFORMED WITHIN THE STUDY PROCEDURE OF THE PERONEAL ARTERY. DESPITE THE USE OF THE SPIDERFX FILTER, POST PROCEDURAL OCCLUSION OF THE PERONEAL ARTERY OCCURRED DUE TO SMALL EMBOLUS. REVASCULARIZATION BY BALLOON ANGIOPLASTY WAS PERFORMED. PLEASE REFERENCE MDR 2183870-2012-00241 FOR THE SPIDERFX USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TURBOHAWK ® PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. THS-LX-C 9618135

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention COTAVANCE BALLOON| AVANT CORDIS 7F SHEATH| SPIDERFX