BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDERFX¿ EMBOLIC PROTECTION DEVICE

    MDR report key: 2072634 · Received April 29, 2011

    Report

    Report Number
    2183870-2011-00079
    Event Type
    Injury
    Date Received
    April 29, 2011
    Date of Event
    March 30, 2011
    Report Date
    March 30, 2011
    Manufacturer
    EV3 INC.
    Product Code
    NTE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THIS REPORTED EVENT.

    Description of Event or Problem · 1

    DURING TREATMENT OF A LONG DIFFUSE AND CALCIFIED SFA LESION IN THE RIGHT LEG, THE PHYSICIAN GAINED ACCESS AND USED .014 300CM WIRE. A 5.0 SPIDERFX WAS OPENED AND PREPPED ACCORDING TO PROCEDURE. THE PHYSICIAN DELIVERED THE SPIDER CATHETER TO THE PATIENT'S RIGHT DISTAL SFA AND WITHDREW THE PRIMARY GUIDEWIRE. USING SHORT STROKES, THE PHYSICIAN THEN ATTEMPTED TO ADVANCE THE CAPTURE WIRE. THE ANGIO VIEW WAS LOOKING AT THE DISTAL END OF THE DELIVERY CATHETER, SO IT WAS NOT POSSIBLE TO SEE IF THE SPIDER WAS ADVANCING. AFTER A HANDFUL OF PUSHES, THE PHYSICIAN PANNED UP TO LOOK AND SAW THE SPIDER HAD NOT ADVANCED OUT OF THE CLEAR SEGMENT OF THE CATHETER. THE PHYSICIAN THEN ATTEMPTED TO WITHDRAW THE DELIVERY CATHETER SINCE THE SPIDER WAS NOT ADVANCING. UPON DOING SO, THE DISTAL PART OF THE GREEN DELIVERY CATHETER, APPROXIMATELY 22.5CM IN LENGTH FROM DISTAL TIP TO THE PRIMARY GUIDEWIRE EXIT PORT, SHEARED OFF AND WAS LODGED INSIDE THE SHEATH. THIS PIECE WAS SPOTTED IN THE LEFT EXTERNAL ILIAC. A 4 MM X 175 SNARE WAS OPENED TO RETRIEVE THE PORTION OF THE DELIVERY CATHETER IN THE SHEATH. BY EMPLOYING THIS DEVICE, IT PUSHED THE PIECE INSIDE THE SHEATH BACK OVER TO THE RIGHT SIDE IN THE EXTERNAL ILIAC WHERE IT WAS SUCCESSFULLY SNARED AFTER A FEW MINUTES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPIDERFX¿ EMBOLIC PROTECTION DEVICE TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE EV3 INC. SPD2-US-050-320 9384359

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SPARTACORE .014 300CM WIRE| GOOSENECK SNARE