BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIOR SL-10 PRE-SHAPED 45 DEGREES MICROCATHER

    MDR report key: 805627 · Received January 3, 2007

    Report

    Report Number
    6000078-2007-00006
    Event Type
    Malfunction
    Date Received
    January 3, 2007
    Date of Event
    December 1, 2006
    Report Date
    December 6, 2006
    Manufacturer
    NEUROVASCULAR, DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQO
    PMA / PMN Number
    K013789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION HAS NOT YET BEEN RETURNED TO BOSTON SCIENTIFIC FOR FURTHER INVESTIGATION. THEREFORE, BOSTON SCIENTIFIC CANNOT CONCLUSIVELY DETERMINE THE CAUSE OF THE USER'S EXPERIENCE. IF THE DEVICE IS RETURNED, AND /OR FURTHER SIGNIFICANT INFORMATION IS FOUND, A SUPPLEMENTAL REPORT WILL FOLLOW. ADDITIONAL 510K#'S K042568/ K994155.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED DURING PROCEDURE, HE ADVANCED THE MICRO-CATHETER ALONG THE GUIDE WIRE TO THE LEFT ESFENOPALATIN ARTERY. THE GUIDE WIRE WAS THEN REMOVED IN ORDER TO INJECT CONTOUR PARTICLES (300-500 MICRONES) THROUGH THE MICRO-CATHETER (A 3CC SYRINGE WAS USED FOR THE INJECTION). IT WAS AT THAT TIME THE PHYSICIAN REPORTEDLY NOTED THAT THE ANGIOGRAPHY WAS NOT SHOWING PARTICLES EXITING THE DISTAL-END OF THE MICRO-CATHETER AS EXPECTED. THE PHYSICIAN CHECKS THE MICRO-CATHETER AND DISCOVERED THAT THE MICRO-CATHETER HAD BROKEN INTO TWO PIECES. BOTH PARTS REMAINED INSIDE THE CARRYING CATHETER. THE BROKEN CATHETER WAS SUCCESSFULLY REMOVED, AND THE PROCEDURE WAS COMPLETED WITH THE USE OF OTHER SIMILAR DEVICES. THERE WAS ALLEGATION OF HARM. THE PHYSICIAN DID STATE THAT HE DID NOT NOTICE ANY ABNORMALITIES OR VISIBLE DAMAGE WHILE IRRIGATING THE DEVICE DURING PREPARATION BEFORE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELSIOR SL-10 PRE-SHAPED 45 DEGREES MICROCATHER (74 DQO) INFUSION CATHETER DQO NEUROVASCULAR, DIVISION OF BOSTON SCIENTIFIC CORPORATION 168190 9002627

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR BERN 5 FR CATHETER| TRANSEND .010 MICRO-GUIDE WIRE