BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIOR SL-10 PRE-SHAPED J MICROCATHETER

    MDR report key: 898800 · Received August 17, 2007

    Report

    Report Number
    6000078-2007-00213
    Event Type
    Malfunction
    Date Received
    August 17, 2007
    Date of Event
    July 25, 2007
    Report Date
    July 25, 2007
    Manufacturer
    BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION
    Product Code
    DQO
    PMA / PMN Number
    K013789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K): K042568, K994155. THE DEVICE IN QUESTION HAS BEEN RETURNED TO BOSTON SCIENTIFIC FOR TECHNICAL ANALYSIS. HOWEVER, THE INVESTIGATION IS STILL PENDING. THEREFORE, THE CAUSE OF THE EVENT REMAINS UNKNOWN AT THIS TIME. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL FOLLOW.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING AN EMBOLIZATION PROCEDURE, FIVE COILS WERE DEPLOYED INTO THE ANEURYSM BUT WERE REPORTEDLY COMPARTMENTALIZING IN ONE AREA. THE PHYSICIAN EXCHANGED AN EXCELSIOR 1018 90 DEGREE MICROCATHETER WITH THE EXCELSIOR SL10 PRE-SHAPED J CATHETER [SUBJECT DEVICE]. UPON INSERTION INTO THE GUIDING CATHETER, RESISTANCE WAS FELT AT THE THREE WAY STOPCOCK EVEN THOUGH THE STOP-COCK HAD BEEN FULLY OPENED. THE TRANSEND EX GUIDEWIRE WAS ADVANCED THROUGH THE CATHETER, AND THE PHYSICIAN ATTEMPTED TO FURTHER ADVANCE THE CATHETER ITSELF WITHOUT RESULT. THE CATHETER WAS THEN REPORTEDLY "PUSHED BY FORCE". A FRACTURE WAS NOTED 5MM FROM THE DISTAL TIP. THE SYSTEM WAS THEN REMOVED FROM THE PATIENT'S BODY AND THE PROCEDURE ENDED. WHEN THE GUIDING CATHETER WAS FLUSHED OUTSIDE OF THE PATIENT, THE FRACTURED DISTAL TIP WAS FLUSHED OUT. THERE WERE NO REPORTED DEVICE RELATED CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELSIOR SL-10 PRE-SHAPED J MICROCATHETER (74DQO) INFUSION CATHETER DQO BOSTON SCIENTIFIC, NEUROVASCULAR DIVISION 168192 9243711

    Patients

    Seq Age Sex Outcome Treatment
    1 YR TRANSEND EX GUIDEWIRE| EXCELSIOR 1018 90 DEGREE MICROCATHETER| 6F ENVOY GUIDING CATHETER