BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDERFX EMBOLIC PROTECTION DEVICE

    MDR report key: 1911731 · Received November 23, 2010

    Report

    Report Number
    2183870-2010-00183
    Event Type
    Injury
    Date Received
    November 23, 2010
    Date of Event
    October 28, 2010
    Report Date
    November 1, 2010
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT PROVIDED.

    Description of Event or Problem · 1

    WHILE USING AN ATHERECTOMY DEVICE OVER THE SPIDER FX WIRE, THE SPIDER WIRE BROKE OFF IN THE SFA. THE WIRE AND BASKET WERE REMOVED WITH A SNARE. NO INJURY TO THE PT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERFX EMBOLIC PROTECTION DEVICE NTE EV3 INC. SPD2-US-US-070-320 9318748

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Required Intervention 7F PINNACLE DESTINATION| JETSTREAM ATHERECTOMY DEVICE