BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDERFX EMBOLIC PROTECTION 2. COMMON DEVICE NAME TEMPORARY CAROTID CATHETER FOR

    MDR report key: 3120585 · Received May 20, 2013

    Report

    Report Number
    2183870-2013-00119
    Event Type
    Injury
    Date Received
    May 20, 2013
    Date of Event
    April 22, 2013
    Report Date
    April 22, 2013
    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 MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    DURING AN ATHERECTOMY OF THE RIGHT SFA, WHILE ADVANCING THE ATHERECTOMY DEVICE, IT APPEARS THAT THE SPIDERFX BASKET STAYED FIXATED TO THE WALL, BUT THE WIRE ADVANCED PAST THE BASKET. PULLING BACK ON THE WIRE ONLY RETRACTED THE BASKET. WHILE ATTEMPTING TO STRAIGHTEN OUT THE WIRE BY SLOWLY ADVANCING A .035 CATHETER AND HOLDING TENSION, THE WIRE SNAPPED AT THE PROXIMAL MARKER BAND BY THE MOUTH OF THE SPIDER. A SNARE TECHNIQUE DID NOT WORK BUT ULTIMATELY THE SPIDER WAS SUCCESSFULLY RETRIEVED BY DEPLOYING A SECOND SPIDER (6MM) DISTAL TO THE DETACHED SPIDER AND PULLING BOTH BACK INTO THE SHEATH FOR FULL CAPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222797 SPIDERFX EMBOLIC PROTECTION 2. COMMON DEVICE NAME TEMPORARY CAROTID CATHETER FOR TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE EV3 INC. SPD2-US-040-320 9450438

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention SPIDERFX 6MM FILTER