BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TURBOHAWK ® PLAQUE EXCISION SYSTEM

    MDR report key: 2696595 · Received August 14, 2012

    Report

    Report Number
    2183870-2012-00155
    Event Type
    Injury
    Date Received
    August 14, 2012
    Date of Event
    July 16, 2012
    Report Date
    July 19, 2012
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 1

    THE PROCEDURE WAS ATHERECTOMY OF THE LEFT LEG FROM RIGHT LEG ACCESS. THE WIRE WRAPPED AROUND THE NOSECONE OF THE TURBOHAWK THS-LS-C W WHILE TRYING TO EXIT OUT THE RIGHT ACCESS AREA. A 10 GOOSE SNARE WAS USED TO REMOVE THE TURBOHAWK WITHOUT SUCCESS. THE LSC, WIRE AND SNARE STAYED IN THE BODY AND THE PATIENT WAS SENT TO SURGERY. THE DEVICES WERE REMOVED IN SURGER AND THE PATIENT HAD A FEM POP PERFORMED BECAUSE OF A POTENTIAL ISSUE WITH THE ARTERY ACCESS. THE PATIENT WAS DISCHARGED HOME ON (B)(6), 2012.

    Description of Event or Problem · 1

    THE PROCEDURE WAS ATHERECTOMY OF THE LEFT LEG FROM RIGHT LEG ACCESS. THE SPIDERFX WIRE WRAPPED AROUND THE NOSECONE OF THE TURBOHAWK THS-LS-C W WHILE TRYING TO EXIT OUT THE RIGHT ACCESS AREA. A 10 GOOSE SNARE WAS USED TO REMOVE THE TURBOHAWK AND WIRE WITHOUT SUCCESS. THE LSC, WIRE AND SNARE STAYED IN THE BODY AND THE PATIENT WAS SENT TO SURGERY. THE DEVICES WERE REMOVED IN SURGERY AND THE PATIENT HAD A FEM POP PERFORMED BECAUSE OF A POTENTIAL ISSUE WITH THE ARTERY ACCESS. THE PATIENT WAS DISCHARGED HOME ON (B)(6), 2012. PLEASE REFERENCE MDR 2183870-2012-00156 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-LS-C 9557764

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention SPIDERFX| GOOSENECK SNARE