BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYCHRO - 14 NEURO GUIDEWIRE

    MDR report key: 776318 · Received August 25, 2006

    Report

    Report Number
    6000078-2006-00379
    Event Type
    Malfunction
    Date Received
    August 25, 2006
    Report Date
    May 1, 2006
    Manufacturer
    NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PMA/510(K) #S: K023700, K002907. BOSTON SCIENTIFIC REQUESTED THE LOT NUMBER AND EVENT DATE, BUT THE SALES REP HAS BEEN UNABLE TO OBTAIN THIS DATA. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED. HOWEVER, THERE WERE SIMILAR COMPLAINTS RELATED TO P/N 1301 AND AN OVERALL EIGHTEEN (18) SIMILAR COMPLAINTS FOR SYNCHRO GUIDE WIRES WITH A COMPLAINT RATE OF 0.07%. SEVERAL PIECES OF GAUZE WITH APPROXIMATELY .45 CM LENGTH (APPROXIMATELY .05 CM WIDTH) OF PTFE COATING ATTACHED TO IT AND PLACED IN A PLASTIC BAG WERE RECEIVED. THE GUIDEWIRE TORQUE DEVICE WERE NOT RETURNED. THE ORIGINAL PACKAGING WAS NOT SUBMITTED SO CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED. A VISUAL EXAM UNDER 40X MAGNIFICATION OF THE RETURNED PTFE COATING INDICATES THE EDGES ARE IRREGULAR POSTULATING THAT THE COATING WAS TORN OR PEELED BY SHEERING FORCES. THE INCIDENT OF THE WIRE COATING SEPARATING FROM THE WIRE IS CONFIRMED FROM VISUAL EXAMINATION OF THE PTFE PIECE THAT WAS RETURNED ONLY. IT HAS BEEN DETERMINED IN PREVIOUS INVESTIGATION LAB STUDIES THAT THE PTFE (TEFLON) COATING CAN BE PEELED-OFF/ABRAIDED AS A RESULT OF THE USER NOT PROPERLY TIGHTENING/SECURING THE TORQUE DEVICE TO THE PROXIMAL REGION OF THE GUIDE WIRE CAUSING SHEERING FORCES ACROSS THE PTFE COATING. THE DIRECTIONS FOR USE (DFU) HAS BEEN AMENDED THROUGH FORMAL CHANGE ORDER, ADDING STRONGER VERBIAGE TO PROPERLY SECURE THE TORQUE DEVICE PRIOR TO MANIPULATION, AS A CAUTION TO THE USER OF THIS TYPE OF FAILURE. HOWEVER, BECAUSE OF AN INCREASE IN COMPLAINTS CONCERNING PTFE COATING PEELING, IT HAS BEEN DETERMINED TO FURTHER ADDRESS THIS ISSUE WITH AN ASSIGNED CAPA. THE CAPA IS CURRENTLY OPEN WITH INVESTIGATION EFFORTS TO DETERMINE THE ROOT CAUSE OF THE PHENOMENON.

    Description of Event or Problem · 1

    THE PHYSICIAN REPORTED THAT THE WIRE COATING SEPARATED. THE PATIENT SUSTAINED NO INJURY OR COMPLICATION AS A RESULT OF THIS EVENT. THE CASE WAS COMPLETED WITH ANOTHER DEVICE OF THE SAME TYPE. THE PHYSICIAN DID NOT DISCLOSED THE SPECIFIC DATE OF THE EVENT OR SUPPLY BOSTON SCIENTIFIC WITH ANY ADDITIONAL INFORMATION REGARDING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYCHRO - 14 NEURO GUIDEWIRE GUIDEWIRE DQX NEUROVASCULAR, A DIVISION OF BOSTON SCIENTIFIC CORPORATION 1301 *

    Patients

    Seq Age Sex Outcome Treatment
    1 *