BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO 14 NEURO GUIDEWIRE

    MDR report key: 885996 · Received September 14, 2006

    Report

    Report Number
    6000078-2005-00274
    Event Type
    Malfunction
    Date Received
    September 14, 2006
    Date of Event
    March 16, 2005
    Report Date
    March 25, 2005
    Manufacturer
    NEUROVASCULAR, A DIV. OF BOSTON SCIENTIFIC CORP
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADD'L: PMA/510(K) # K023700, K002907. THE PRESENCE OF HYDROPHILIC COATING WAS OBSERVED DURING THE VISUAL EVAL. BOSTON SCIENTIFIC CANNOT CONFIRM THE USER'S EXPERIENCE OF A RUPTURED HYDROPHILIC COATING. FURTHER, LUBRICITY TESTING WAS PERFORMED ON THIS LOT OF PRODUCT AS PART OF THE ROUTINE PRODUCTION MONITORING, ALL RESULTS INDICATED THAT THE SPECS WERE MET. THE RETURNED WIRE HAD A SEPARATION IN THE NITINOL SLEEVE AND CORE WIRE THAT OCCURRED APPROXIMATELY 12CM FROM THE DISTAL TIP OF THE WIRE. THE DISTAL TIP WAS STILL ATTACHED BY THE PLATINUM COIL THAT HAD STRETCHED OVER A 3CM LENGTH. THE BREAK OCCURRED APPROXIMATELY 3CM DISTAL TO THE PROXIMAL END OF THE SOLDER JOINT MADE ON THE PLATINUM COIL. THE SEPARATION POINTS WERE EXAMINED UNDER 40X MAGNIFICATION, AND NOTED TO BE A CLEAN BREAK (MEANING THERE WERE NO RINGS OR BEAMS STRETCHED AND NO CROSS-SECTIONAL AREA REDUCTION OF THE CORE WIRE WAS OBSERVED THAT WOULD SUGGEST A TENSILE TYPE BREAK). CHARACTERISTICS SUGGESTING THE WIRE MAY HAVE BEEN CUT, WERE NOT VISIBLE; THEREFORE, IT WAS DETERMINED THAT THE BREAK/SEPARATION IS INDICATIVE OF A TORSION TYPE BREAK. THE SEGMENTS ARE OTHERWISE NORMAL IN APPEARANCE AND PRESENT NO USUAL SIGNS OF ALTERATION, ABUSE, OR DAMAGE. THE OBSERVED CHARACTERISTICS OF THE BROKEN SEGMENTS IS TYPICAL OF BREAKS THAT OCCUR FROM A COMBINATION OF BUCKLING/PROLAPSED AND TORQUE IN THE SYSTEM. A SIMILAR TYPE BREAK HAS OCCURRED DURING SIMULATED TESTING WHEN A GUIDE WIRE OR GUIDE WIRE/CATHETER IN THE VASCULAR SYSTEM PROLAPSES OR BUCKLES FOLLOWED BY APPLICATION OF NOTABLE TORQUE OR A COMBINATION OF TORQUE AND TENSILE TENSION. BECAUSE OF THE FLEXIBILITY AND DELICATE NATURE OF THESE PRODUCTS, BUCKLING AND PROLAPSING MAY OCCUR WHEN A VASCULAR BIFURCATION EXISTS AND A LOOPING OF THE PRODUCT OCCURS IN BOTH ARMS OF THE VASCULAR PATH(S). BOSTON SCIENTIFIC COULD NOT CONFIRM THAT THE HYDROPHILIC COATING RUPTURED, AS THE COATING WAS PRESENT DURING THE INVESTIGATION. BOSTON SCIENTIFIC BELIEVES THE USER MAY BE REFERRING TO THE BREAK FOUND IN THE DISTAL SECTION OF THE RETURNED WIRE. HOWEVER, NO INFO WAS GIVEN AS TO WHETHER THE FULL LENGTH OF THE GUIDE WIRE HAD BEEN VERIFIED RADIOGRAPHICALLY, OR IF ONLY THE DISTAL SEGMENT PLACEMENT WAS BEING VIEWED DURING DEPLOYMENT. THE DEVICE HISTORY RECORD WAS REVIEWED AND THERE WERE NO ISSUES OR DISCREPANCIES RELATING TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC HAS BECOME AWARE OF THE FOLLOWING EVENT AFTER CONDUCTING A RETROSPECTIVE REVIEW OF COMPLAINT RECORDS: THE PHYSICIAN REPORTED THAT THE HYDROPHILIC COATING ON THE DISTAL PART OF THE GUIDEWIRE RUPTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO 14 NEURO GUIDEWIRE GUIDEWIRE DQX NEUROVASCULAR, A DIV. OF BOSTON SCIENTIFIC CORP 1302 B01805

    Patients

    Seq Age Sex Outcome Treatment
    1 *