BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIOR SL-10 PRE-SHAPED 45 DEGREES MICROCATHETER

    MDR report key: 842165 · Received April 25, 2007

    Report

    Report Number
    6000078-2007-00119
    Event Type
    Malfunction
    Date Received
    April 25, 2007
    Date of Event
    March 29, 2007
    Report Date
    March 30, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIV
    Product Code
    DQO
    PMA / PMN Number
    K013789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA / 510 (K)#: K042568/K994155.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC ON 03/30/2007, THAT THE PHYSICIAN TRIED TO PUSH THE SILVERSPEED 14 THROUGH THE CATHETER (DEVICE IN QUESTION) AND FELT HEAVY RESISTANCE INSIDE THE CATHETER. " IT SEEMED AS IF BOTH DEVICES WERE STUCK TOGETHER." UNDER FLUOROSCOPY, THE PHYSICIAN COULD SEE THAT THE GUIDE WIRE COULD NOT BE PUSHED OUTSIDE THE CATHETER. AFTER REMOVAL OF BOTH PRODUCTS, HE SAW THAT BOTH TIP MARKERS OF THE CATHETER WERE MISSING. THE PHYSICIAN FOUND THE REST OF THE CATHETER AT THE DISTAL END OF THE SILVERSPEED. AFTERWARDS, THE PHYSICIAN USED ANOTHER DEVICE OF THE SAME TYPE WITH A SYNCHRO WIRE AND 2 GDC COILS AND FINISHED THE PROCEDURE SUCCESSFULLY. IT WAS REPORTED THAT THE "PATIENT STATUS IS OK" AND THAT THERE WERE NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELSIOR SL-10 PRE-SHAPED 45 DEGREES MICROCATHETER 74 DQO - INFUSION CATHETER DQO BOSTON SCIENTIFIC CORPORATION, NEUROVASCULAR DIV 168190 9120949

    Patients

    Seq Age Sex Outcome Treatment
    1 YR SILVERSPEED 14 GUIDEWIRE (NON-BSC)