BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO 2 GUIDEWIRE

    MDR report key: 1193418 · Received October 8, 2008

    Report

    Report Number
    2939204-2008-00452
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    August 20, 2008
    Report Date
    October 3, 2008
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K053268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: OTHER FOR HANDLING DAMAGE. THE DEVICE HISTORY RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT THE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS MISSING 18.4CM FROM THE PROXIMAL END, THERE WAS A SLIGHT BEND 34.5CM FROM THE DISTAL END AND THE DISTAL TIP HAD SEPARATED APPROXIMATELY 3.6CM FROM THE DISTAL END. THE DISTAL TIP WAS NOT RETURNED. NO OTHER ANOMALIES WERE FOUND ON THE DEVICE. THE DEVICE WAS LOADED INTO A DEMONSTRATION MICROCATHETER PROXIMAL END AND ADVANCED TO THE DISTAL END WITHOUT ANY DIFFICULTY. THE DAMAGE TO THE COATING AND THE KINK ARE INDICATIVE OF RESISTANCE/JAMMING BETWEEN THE DEVICE AND MICROCATHETER. THE DEFINITIVE CAUSE FOR THE RESISTANCE ENCOUNTERED AND THE SEPARATION OF THE DISTAL TIP CANNOT BE DETERMINED. FROM ADDITIONAL INFORMATION PROVIDED, IT WAS DETERMINED THAT THERE WAS NO DAMAGE OBSERVED TO THE DEVICE OR MICROCATHETER DURING PREPARATION AND THE DEVICES WERE PREPARED IN ACCORDANCE TO THEIR RESPECTIVE DIRECTIONS FOR USE. THE OBSERVED DAMAGES MOST LIKELY OCCURRED DURING PREPARATION OR, AS A RESULT OF THE REPORTED RESISTANCE ENCOUNTERED DURING THE PREPARATION TO USE THE DEVICES IN THE PROCEDURE; SO, A ROOT CAUSE OF HANDLING DAMAGE WAS ASSIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PREPARATION, AS THE GUIDEWIRE WAS BEING LOADED INTO THE MICROCATHETER, IT BECAME "EFFECTIVELY STUCK" IN THE MICROCATHETER AND THE PHYSICIAN WAS UNABLE TO ADVANCE OR RETRACT THE GUIDEWIRE. THE DEVICES WERE NOT USED IN THE PROCEDURE. EVALUATION OF THE RETURNED GUIDEWIRE FOUND THAT PART OF THE DISTAL TIP HAD SEPARATED FROM THE DEVICE AND THE COATING WAS PEELING AT THE PROXIMAL END.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO 2 GUIDEWIRE (DQX) GUIDEWIRE DQX NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION 2601 B14178

    Patients

    Seq Age Sex Outcome Treatment
    1 BOSTON SCIENTIFIC EXCELSIOR SL10 MICROCATHETER