BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK® PLAQUE EXCISION SYSTEM

    MDR report key: 2883991 · Received December 21, 2012

    Report

    Report Number
    2183870-2012-00252
    Event Type
    Injury
    Date Received
    December 21, 2012
    Date of Event
    November 21, 2012
    Report Date
    December 19, 2012
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    THE PHYSICIAN PERFORMED ATHERECTOMY OF THE LEFT PERONEAL ARTERY WITH THE SILVERHAWK ES+. THE LOCATION WAS DISTAL NEAR THE ANKLE. UPON COMPLETION, THE PHYSICIAN ATTEMPTED TO REMOVE THE SILVERHAWK. WHEN EXTRACTING THE SILVERHAWK, THE GUIDE WIRE WAS LOOPED IN THE PROXIMAL SEGMENT OF THE ARTERY. THE WIRE COULD NOT BE STRAIGHTENED OUT. THE SILVERHAWK WAS REMOVED, CUTTING THE WIRE IN HALF. THE REMAINING WIRE WAS IN THE PATIENT. THE PHYSICIAN USED RETRIEVAL FORCEPS AND REMOVED THE REMAINING WIRE WITH OUT COMPLICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK® PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. ES+ 9629206

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R NANOCROSS BALLOON| (B)(4) JOURNEY WIRE