BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX 014/205 FLOPPY

    MDR report key: 4152665 · Received October 8, 2014

    Report

    Report Number
    3008853977-2014-00325
    Event Type
    Malfunction
    Date Received
    October 8, 2014
    Date of Event
    June 3, 2014
    Report Date
    July 2, 2014
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K944677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE GUIDEWIRE WAS RECEIVED IN TWO PIECES: THE DISTAL SECTION MEASURED 112.0CM AND THE PROXIMAL SECTION MEASURED 92.0CM. VISUAL INSPECTION OF THE DEVICE FOUND SEVERAL KINKS ON THE PROXIMAL SECTION. MAGNIFIED EXAMINATION OF THE FRACTURE SITE SHOWED THE CORE WIRE WAS FRACTURED. THERE APPEARS TO BE SOME DISCOLORATION AT THE FRACTURE SITE. THE DISCOLORATION AT THE FRACTURES SITE OF THE DEVICE IS BELIEVED TO BE CORROSION DUE TO ITS APPEARANCE AND THE EXTENDED TIME PERIOD THAT THE DEVICE REMAINED IN THE DISPENSER HOOP. A FUNCTIONAL TEST WAS NOT PERFORMED DUE TO THE OBSERVED ANOMALIES. NO OTHER ANOMALIES WERE NOTED. FROM THE CONDITION OF THE GUIDEWIRE AT THE FRACTURE SITE, IT APPEARS THAT THE GUIDEWIRE WAS BENT FIRST AND THEN SEPARATED. THE BENDING AND THE FRACTURE ON THE GUIDEWIRE APPEARED TO BE DUE TO EXCESSIVE MANIPULATION. BOTH PIECES OF THE GUIDEWIRE WERE FURTHER ANALYZED USING SCANNING ELECTRON MICROSCOPY (SEM). THIS REVEALED THAT A FAILURE OCCURRED DUE TO A BENDING OVERLOAD FOLLOWED BY A FINAL TENSION MOMENT AND BOTH SAMPLES ARE LIKELY TO BE CORRESPONDING PIECES DUE TO SIMILAR CHARACTERISTICS. FROM THE INFORMATION PROVIDED AND INVESTIGATION RESULTS THERE WAS NO INDICATION THAT THE DEVICE WAS NOT USED AS IN ACCORDANCE WITH THE LABELING OR THAT THIS CAUSED OR CONTRIBUTED TO THE OBSERVED ISSUES. BECAUSE REVIEW AND ANALYSIS OF AVAILABLE INFORMATION AND INVESTIGATION RESULTS FAILED TO IDENTIFY A DEFINITIVE CAUSE, A CAUSE OF UNDETERMINABLE WAS ASSIGNED TO THE OBSERVED GUIDEWIRE BREAKAGE. DURING VISUAL INSPECTION OF THE RETURNED DEVICE IT WAS FOUND THAT THE PTFE COATING WAS SCRAPED OFF ON SEVERAL PLACES ALONG ITS PROXIMAL APPROXIMATELY 40CM LENGTH. THE PTFE COATING APPEARED TO BE SCRAPED OFF OF THE GUIDEWIRE WITH THE TORQUE DEVICE COLLET. THE GUIDEWIRE HYDROPHILIC COATING WAS EXAMINED; THE COATING IS PRESENT ON THE GUIDEWIRE AND MEETS VISUAL SPECIFICATIONS. THE DIRECTIONS FOR USE (DFU) CAUTIONS TO: ¿EXCESSIVE TIGHTENING OF THE TORQUE DEVICE ONTO THE WIRE MAY RESULT IN ABRASION OF THE COATING OF THE WIRE¿. THE OBSERVED PEELING PTFE COATING IS BELIEVED TO HAVE OCCURRED FROM AN EXCESSIVELY TIGHTENED TORQUE DEVICE. SINCE THE DFU SPECIFICALLY CAUTIONS THAT EXCESSIVE TIGHTENING OF THE TORQUE DEVICE CAN LEAD TO ABRASION OF THE COATING, THE CAUSE IS CONSIDERED TO BE RELATED TO THE DFU INSTRUCTION NOT BEING FOLLOWED.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE GUIDEWIRE WAS SEPARATED IN TWO PIECES AND THE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS PEELED OFF. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE GUIDEWIRE WAS SEPARATED IN TWO PIECES AND THE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS PEELED OFF. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    630250 TRANSEND EX 014/205 FLOPPY WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 16398798

    Patients

    Seq Age Sex Outcome Treatment
    1 EXCELSIOR SL-10 MICROCATHETER (STRYKER)