BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX 014/205 PLATINUM

    MDR report key: 3899680 · Received June 27, 2014

    Report

    Report Number
    3008853977-2014-00198
    Event Type
    Malfunction
    Date Received
    June 27, 2014
    Date of Event
    June 5, 2014
    Report Date
    June 10, 2014
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K971254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    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 PROXIMAL SECTION WAS MEASURED 94.5CM AND THE DISTAL SECTION WAS MEASURED 108.5CM. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THAT BOTH PIECES WERE BENT ON SEVERAL PLACES ALONG ITS LENGTH. MAGNIFIED EXAMINATION OF THE FRACTURE SITE SHOWED THE CORE WIRE WAS FRACTURED. NO BENDING AND OR STRETCHING ON THE GUIDEWIRE WAS NOTICED. FROM THE CONDITION OF THE GUIDEWIRE AT THE FRACTURE SITE, IT APPEARS THAT THE GUIDEWIRE WAS SEPARATED DUE TO OVER TORQUE. THE BENDING ON THE GUIDEWIRE APPEARED TO BE DUE TO EXCESSIVE MANIPULATION. THE FRACTURE ON THE GUIDEWIRE APPEARED TO BE DUE TO THE EXCESSIVE MANIPULATION AND TORSIONAL OVERLOAD. HOWEVER, REVIEW AND ANALYSIS OF AVAILABLE INFORMATION AND INVESTIGATION RESULTS FAILED TO IDENTIFY A DEFINITIVE ROOT CAUSE FOR THE REPORTED EVENT AND OBSERVED ISSUES. THE GUIDEWIRE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS FOUND TO BE SCRAPED OFF ON SEVERAL PLACES ALONG ITS PROXIMAL APPROXIMATELY 38.0CM LENGTH. THE PTFE COATING APPEARED TO BE SCRAPED OFF OF THE GUIDEWIRE WITH THE TORQUE DEVICE COLLET. NO ANOMALIES WERE OBSERVED WITH THE HYDROPHILIC COATING. 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 COATING DAMAGE ON THE PROXIMAL END OF THE GUIDEWIRE WAS PROBABLY DUE TO THE INSUFFICIENT TIGHTENING OF THE TORQUE DEVICE. THEREFORE, A ROOT CAUSE OF DFU INSTRUCTIONS NOT FOLLOWED HAS BEEN ASSIGNED TO THIS OBSERVATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TORQUING THE GUIDEWIRE APPROXIMATELY 3-5 CM OF THE DISTAL TIP BROKE OFF. THE GUIDEWIRE WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING TORQUING THE GUIDEWIRE APPROXIMATELY 3-5 CM OF THE DISTAL TIP BROKE OFF. THE GUIDEWIRE WAS COMPLETELY REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED USING ANOTHER OF THE SAME DEVICE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT DUE TO THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    376724 TRANSEND EX 014/205 PLATINUM WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 16469331

    Patients

    Seq Age Sex Outcome Treatment
    1 TRANSFORM OCCLUSION BALLOON CATHETER (STRYKER)