BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND GUIDEWIRE

    MDR report key: 1193422 · Received October 8, 2008

    Report

    Report Number
    2939204-2008-00454
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    June 16, 2008
    Report Date
    September 16, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K022357
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED TO BOSTON SCIENTIFIC. UPON VISUAL EXAMINATION PERFORMED ON THE GUIDEWIRE, IT WAS OBSERVED THAT THE SPRING TIP WAS FORMED INTO A LOOP AND ELONGATED APPROXIMATELY 2 MM FROM THE PROXIMAL SOLDER POINT. THE WIRE WAS FOUND TO BE KINKED ALONG ITS ENTIRE LENGTH. FURTHER OBSERVATION FOUND THAT THE PTFE COATING WAS SCRAPPED APPROXIMATELY 134 CM THROUGH 140 CM FROM THE DISTAL TIP OF THE SUBJECT DEVICE. THERE WERE NO FURTHER ANOMALIES NOTED TO THE SUBJECT DEVICE. NO FURTHER INFO HAS BEEN RECEIVED TO INDICATE THAT THE DEVICE WAS NOT USED AS INSTRUCTED IN THE DIRECTIONS FOR USE. THE DEVICE HISTORY RECORD REVIEW DID NOT INDICATE ANY ISSUES OR DISCREPANCIES DURING THE MANUFACTURING PROCESS OF THE RETURNED GUIDEWIRE THAT COULD HAVE CONTRIBUTED TO EITHER THE REPORTED ISSUES OR OBSERVED ANOMALIES. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION IN REGARDS TO THE SUBJECT DEVICE; HOWEVER, NO RESPONSE WAS RECEIVED BACK FROM THE FACILITY. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED BASED ON THE LIMITED INFORMATION AVAILABLE. IT IS PROBABLE THAT THE DAMAGE TO THE COATING OCCURRED FOLLOWING THE WIRE KINKING; THEREFORE, A ROOT CAUSE OF OPERATIONAL CONTEXT WAS ASSIGNED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC THAT THE SUBJECT GUIDEWIRE KINKED DURING THE PROCEDURE. ANALYSIS OF THE RETURNED DEVICE NOTED THE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS PEELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRANSEND GUIDEWIRE (DQX) WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC CORPORATION 46-815 11434276

    Patients

    Seq Age Sex Outcome Treatment
    1