BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK PLAQUE EXCISION SYSTEM

    MDR report key: 2881899 · Received December 20, 2012

    Report

    Report Number
    2183870-2012-00251
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    November 15, 2012
    Report Date
    December 14, 2012
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS UNAVAILABLE. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD IT BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    UPON INSERTION, AFTER CLEANING, THE SILVERHAWK BECAME STUCK IN THE SHEATH. THE PHYSICIAN COULD NOT REMOVE IT, AND HAD TO CUT SHEATH WHILE IT WAS STILL LOCATED IN THE GROIN, TO REMOVE THE SILVERHAWK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERHAWK PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. LS-M UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SPARTACORE 014 WIRE