BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO 2 GUIDEWIRE

    MDR report key: 1193420 · Received October 8, 2008

    Report

    Report Number
    2939204-2008-00455
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    July 30, 2008
    Report Date
    September 18, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K053268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DURING ANALYSIS OF THE RETURNED SUBJECT DEVICE (GUIDEWIRE), IT WAS DISCOVERED THAT THE GUIDEWIRE'S (PTFE) COATING WAS DAMAGED SEVERAL PLACES ALONG THE PROXIMAL END. THE COATING WAS DAMAGED FROM 53.0 CM FROM ITS PROXIMAL END. FROM THE CONDITION OF THE GUIDEWIRE, IT APPEARS THAT THE TORQUE DEVICE HAD BEEN DRAGGED DOWN THE WIRE. THE TORQUE DEVICE WAS NOT RETURNED. THE GUIDEWIRE WAS SHAPED ON ITS DISTAL SECTION. THE SHEERING/PEELING OF THE PTFE COATING HAS SECTIONS WHERE THE COATING IS PARTIALLY PEELED UP FROM THE STAINLESS STEEL COREWIRE. A VISUAL EXAMINATION ON THE REMAINDER OF THE PTFE COATING (ENTIRE PTFE COATED SECTION) DID NOT REVEAL ANY OTHER UNUSUAL ABNORMALITIES IN THE COATING (I.E. NO COATING BLISTERS, BUBBLES OR IRREGULAR SURFACES). ADDITIONALLY, IT WAS NOTED THAT THE GUIDEWIRE WAS SLIGHTLY BENT AT 163.5CM FROM ITS PROXIMAL END. NO OTHER ANOMALIES WERE OBSERVED WITH THE GUIDEWIRE. IT SHOULD BE NOTED THAT THE DIRECTIONS FOR USE INCLUDES SPECIFIC WARNINGS FOR INADEQUATELY TIGHTENING DOWN THE TORQUE DEVICE. THUS USER ERROR IS CONSIDERED THE CAUSE OF THE OBSERVED PTFE PEELING. THE EXCELSIOR SL-10 CATHETER USED IN CONJUNCTION WITH THIS GUIDEWIRE WAS ALSO RETURNED AND EVALUATED. THE SUBJECT DEVICE WAS INTRODUCED AND ADVANCED INTO THE MICROCATHETER THROUGH ITS PROXIMAL END. WHILE THE GUIDEWIRE CAME OUT OF THE MICROCATHETER DISTAL END, IT SHOULD BE NOTED THAT THE GUIDEWIRE ENCOUNTERED FRICTION WHILE IT WAS BEING PUSHED THROUGH THE MICROCATHETER. THIS FRICTION APPEARED TO BE DUE TO THE ANOMALIES FOUND ON THE MICROCATHETER. FURTHER INSPECTION OF THE MICROCATHETER FOUND THAT THE EXCELSIOR SL-10 MICROCATHETER WAS SLIGHTLY BENT AT 117.5CM FROM ITS PROXIMAL END. THE MICROCATHETER WAS KINKED AT 0.7CM FROM ITS DISTAL END. NO OTHER ANOMALIES WERE FOUND TO BE VISIBLE TO THE DEVICE. THE FRICTION IN THE SYSTEM THAT WAS FELT LED TO THE PHYSICIAN HAVING TO EXERT EXCESSIVE FORCE DURING ADVANCEMENT TO OVERCOME THE FRICTION WHICH SUBSEQUENTLY RESULTED IN THE OBSERVED DAMAGES ON BOTH THE CATHETER AND GUIDEWIRE IN THIS CASE. EXCESSIVE FORCE DURING USE IN ORDER TO OVERCOME PROCEDURAL AND/OR ANATOMICAL FACTORS THEREFORE LIKELY ACCOUNTS FOR THE OBSERVED DAMAGES TO THE CATHETER AS WELL AS THE BEND NOTED ON THE GUIDEWIRE. THE DAMAGES OBSERVED ON THE CATHETER ARE KNOWN TO CAUSE OR CONTRIBUTE TO FRICTION DURING ADVANCEMENT OVER A GUIDEWIRE. ALTHOUGH DAMAGE WAS NOTED TO THE GUIDEWIRE, IT HAS BEEN CONCLUDED THAT IT WAS THE DAMAGE TO THE CATHETER THAT LIKELY LED TO THE RESISTANCE FELT BY THE PHYSICIAN AND NOT THE OBSERVED PEELING OR BEND ON THE GUIDEWIRE. THE DEVICE HISTORY RECORD REVIEW INDICATES BOTH THE CATHETER AND GUIDEWIRE DEVICES MET SPECIFICATIONS PRIOR TO RELEASE. SINCE THE FRICTION EXPERIENCED DURING USE OF THE GUIDEWIRE WAS CAUSED BY DAMAGE ON THE CATHETER, A ROOT CAUSE CLASSIFICATION OF CAUSED BY OTHER DEVICE HAS BEEN ASSIGNED.

    Description of Event or Problem · 1

    WHILE TRYING TO ADVANCE THE GUIDEWIRE (SUBJECT DEVICE) THROUGH AN EXCELSIOR SL-10 CATHETER, TO THE RIGHT INTERNAL CAROTID ARTERY (ICA) RESISTANCE WAS FELT. THE DEVICE WAS RETURNED FOR EVALUATION AND THE DEVICE WAS FOUND TO BE BENT AND THE POLYTETRAFLUORO ETHYLENE (PTFE) COATING WAS DAMAGED ON SEVERAL PLACES 53.0 CM FROM ITS PROXIMAL END OF THE SUBJECT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO 2 GUIDEWIRE NEURO GUIDEWIRE (DQX) DQX BOSTON SCIENTIFIC CORPORATION 2601 B14189

    Patients

    Seq Age Sex Outcome Treatment
    1 BOSTON SCIENTIFIC EXCELSIOR SL-10 CATHETER