BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPINNAKER ELITE FLOW DIRECTED CATHETER 1.8 F-S W/HYDROLENE

    MDR report key: 491979 · Received October 24, 2003

    Report

    Report Number
    6000078-2003-00170
    Event Type
    Malfunction
    Date Received
    October 24, 2003
    Date of Event
    September 25, 2003
    Report Date
    October 23, 2003
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC WAS NOTIFIED OF THE FOLLOWING EVENT DURING AN AVM EMBOLIZATION PROCEDURE: A 1.7F LONG SHEATH WAS INSERTED IN THE RIGHT FEMORAL ARTERY AND A 6F ENVOY MPD 100CM(CORDIS) WAS APPROACHED TO THE RIGHT INTERNAL CAROTID ARTERY (WITH 4F CATHETER OK2M AMD AQUA 0.035 INCHES GW(J&J). A PROWLER 14J (CORDIS, MC) AND AGILITY 14 (J&J, GW) WERE APPROACHED TO THE FIRST FEEDER AND IT EMBOLIZED AT 0.25CC OF NBCA AND LIPIODOL(50%). THE CATHETER AND THE AGILITY 10 WERE APPROACHED TO THE SECOND FEEDER. 0.2CC OF NBCA AND LIPIODOL (50%) WERE INFUSED AND THE CATHETER WAS PULLED OUT WITH RESISTANCE. WHEN THE ANGIOGRAPHY WAS PERFORMED FOR CONFIRMATION, AN OBJECT LIKE THE MARKER WAS FOUND NEAR THE SIDE OF THE NIDUS. WHEN PHYSICIAN CHECKED THE CATHETER, HE FOUND THE DISTAL SHAFT WAS BROKEN. THE BROKEN TIP REMAINS INSIDE THE PATIENT NEAR THE NIDUS. THE PROCEDURE WAS CONTINUED. THE PROWLER 10STR AND AGILTY 10 WERE APPROACHED TO THE THIRD FEEDER, AND IT EMBOLIZED AT 0.2CC OF NBCA AND LIPIODOL(50%). THE PROWLER 10J AND AGILTY 10 WERE APPROACHED TO THE FOURTH FEEDER, BUT THIS WASN'T SUCCESSFUL. BUT SINCE THE ANGIOGRAPHY FOR CONFIRMATION WAS PERFORMED, AND THE NIDUS WAS CONTRACTIVE COMPARED WITH BEFORE PROCEDURE, THE PROCEDURE WAS COMPLETED. PATIENT CONDITION AFTER THE PROCEDURE WAS DESCRIBED AS BEING GOOD. NO INTERVENITON AND/OR SURGERY WERE REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SPINNAKER ELITE FLOW DIRECTED CATHETER 1.8 F-S W/HYDROLENE FLOW DIRECTED CATHETER KRA BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIVISION * 5196648

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR BRAND NAME: NBCA.| BRAND NAME: J & J AQUA 0.035" GUIDEWIRE.| BRAND NAME: LIPIODOL.| BRAND NAME: CORDIS 6F ENVOY MPD 100CM.| BRAND NAME: CORDIS PROWLER 14.| BRAND NAME: 4F CATHEX OK2M.| BRAND NAME: PROWLER 10STR.| BRAND NAME: AGILITY 10 GUIDEWIRE.| BRAND NAME: PROWLER 10.| BRAND NAME: JOHNSON & JOHNSON AGILITY 14 GUIDEWIRE| BRAND NAME: 1.7F LONG SHEATH.