BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SILVERHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM

    MDR report key: 2963022 · Received February 15, 2013

    Report

    Report Number
    2183870-2013-00043
    Event Type
    Injury
    Date Received
    February 15, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    EV3 INC.
    Product Code
    MCW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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. THE INSTRUCTIONS FOR USE (IFU) ADVISE, "IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING. NEVER ADVANCE THE DISTAL TIP OF THE CATHETER NEAR THE FLOPPY END OF THE GUIDEWIRE. A CATHETER ADVANCED TO THIS POSITION MAY NOT FOLLOW THE GUIDEWIRE WHEN IT IS RETRACTED AND CAUSE THE GUIDEWIRE TO BUCKLE INTO A LOOP. IF THIS OCCURS, CATHETER AND GUIDEWIRE SHOULD BE REMOVED TOGETHER TO PREVENT POTENTIAL DAMAGE TO VESSEL WALLS. IF RESISTANCE IS STILL FELT, THE SHEATH SHOULD ALSO BE REMOVED AS PART OF THE UNIT."

    Description of Event or Problem · 1

    THE PROCEDURE WAS TIBIAL ATHERECTOMY, VIA THE LEFT COMMON FEMORAL. UPON REMOVING THE SILVERHAWK DEVICE AFTER TREATMENT, THE PHYSICIAN FELT RESISTANCE AND NOSECONE SHEARED OFF. THE NOSECONE WAS SNARED AND REMOVED WITH NO HARM TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    68901 SILVERHAWK ® PERIPHERAL PLAQUE EXCISION SYSTEM CATHETER, PERIPHERAL, ATHERECTOMY MCW EV3 INC. P4033 9586989

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention