BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX 014/205 PLATINUM

    MDR report key: 8120973 · Received November 30, 2018

    Report

    Report Number
    3008853977-2018-00069
    Event Type
    Malfunction
    Date Received
    November 30, 2018
    Date of Event
    October 8, 2018
    Report Date
    January 3, 2019
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    UDI-DI
    08714729326267
    PMA / PMN Number
    K971254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H4 MANUFACTURING DATE: ADDED. H3 DEVICE EVALUATED BY MFG: UPDATED. H3 SUMMARY ATTACHED: UPDATED. D4 EXPIRATION DATE: ADDED. D10 PRODUCT AVAILABLE TO STRYKER: UPDATED. D10 RETURNED TO MANUFACTURER ON: UPDATED. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MICROCATHETER USED WITH THE GUIDEWIRE WAS NOT RETURNED. THE TORQUE DEVICE WAS RETURNED. MAGNIFIED INSPECTION REVEALED THAT THE GUIDEWIRE WAS RECEIVED IN TWO FRAGMENTS AND THAT THE CORE WIRE WAS FRACTURED. THE GUIDEWIRE WAS KINKED AT THE FRACTURE SITE AS WELL. FROM THE CONDITION OF THE GUIDEWIRE AT THE FRACTURE SITE, IT APPEARS THAT THE GUIDEWIRE SEPARATED DUE TO EXCESSIVE BENDING, KINKING AND EXCESSIVE TORQUE. THE GUIDEWIRE WAS FOUND TO BE BENT PROXIMAL TO THE SEPARATED SITE AND KINKED ON SEVERAL PLACES ALONG ITS PTFE (POLYTETRAFLUOROETHYLENE) LENGTH. NO ANOMALIES WERE OBSERVED WITH THE HYDROPHILIC AND PTFE COATING. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED GUIDEWIRE. INFORMATION AVAILABLE INDICATED THAT THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION PRIOR TO USE,NO FRICTION WAS ENCOUNTERED DURING THE PROCEDURE AND THE GUIDEWIRE MOVED FREELY WITHIN THE CATHETER. IT WAS ALSO REPORTED THAT CONTINUOUS FLUSH WAS NOT MAINTAINED AND THE DEVICE HAD ALREADY BEEN USED ONCE, RE-HOOPED AND WHEN IT WAS BEING REINTRODUCED INTO THE CATHETER, THE GUIDEWIRE WAS NOTED TO HAVE SNAPPED MIDWAY THROUGH RE-INTRODUCTION. BASED ON ANALYSIS, IT APPEARED THAT THE GUIDEWIRE MAY HAVE GONE THROUGH EXCESSIVE MANIPULATION DURING THE PROCEDURE. IT IS ALSO POSSIBLE THAT SINCE CONTINUOUS FLUSH WAS NOT USED, THE GUIDEWIRE MAY HAVE LOST ITS LUBRICITY AND DURING RE-HOOPING AND REINTRODUCTION OF THE GUIDEWIRE INTO CATHETER, EXCESSIVE MANIPULATION MAY HAVE CAUSED THE GUIDEWIRE TO BREAK. THEREFORE BASED ON ALL OF THE INFORMATION AVAILABLE, AN ASSIGNABLE CAUSE OF HANDLING DAMAGE WAS ASSIGNED TO THE OBSERVED AND REPORTED DAMAGES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE GUIDEWIRE HAD BROKEN DURING USE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE GUIDEWIRE HAD BROKEN DURING USE. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    959600 TRANSEND EX 014/205 PLATINUM WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 21452696 08714729326267

    Patients

    Seq Age Sex Outcome Treatment
    1 MICROCATHETER (UNKNOWN MANUFACTURER)