BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX 014/205 FLOPPY

    MDR report key: 8116118 · Received November 29, 2018

    Report

    Report Number
    3008853977-2018-00067
    Event Type
    Malfunction
    Date Received
    November 29, 2018
    Date of Event
    September 11, 2018
    Report Date
    November 29, 2018
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    UDI-DI
    08714729326250
    PMA / PMN Number
    K944677
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE GUIDEWIRE WAS RECEIVED IN TWO FRAGMENTS AND THE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS SCRAPPED CLOSED TO THE FRACTURE SITE. MAGNIFIED EXAMINATION OF THE FRACTURE SITE SHOWED THE CORE WIRE WAS FRACTURED AND THE GUIDEWIRE WAS KINKED. IT APPEARS THAT THE GUIDEWIRE SEPARATED DUE TO KINKING; LIKELY DUE TO SOME PROCEDURAL FACTORS ENCOUNTERED DURING USE. FROM THE CONDITION OF THE DEVICE, THE FUNCTIONAL TEST COULD NOT BE PERFORMED. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT GUIDEWIRE WAS INSPECTED AND CONFIRMED TO BE IN GOOD CONDITION AFTER UNPACKING AND DURING PREPARATION, THE GUIDEWIRE WAS PREPARED PER THE DEVICE DIRECTION FOR USE (DFU) INSTRUCTIONS AND SLIGHT RESISTANCE WAS ENCOUNTERED WHILE REMOVING THE GUIDEWIRE FROM THE DISPENSER HOOP. BASED ON THE CONDITION OF THE FRACTURE AND THE SCRAPPING OF THE PTFE COATING, IT APPEARS THAT THE OTHER ANOMALIES (FRACTURE AND PTFE PEELING) NOTED DURING THE DEVICE ANALYSIS WERE CAUSED BY EXCESSIVE MANIPULATION DURING THE PROCEDURE. THEREFORE, A CAUSE OF 'HANDLING DAMAGE" HAS BEEN ASSIGNED TO THE ANALYZED CODES "GUIDEWIRE BROKEN" AND "GUIDEWIRE PTFE COATING PEELING".

    Description of Event or Problem · 1

    ANALYSIS OF THE RETURNED DEVICE REVEALED THAT THE SUBJECT DEVICE WAS RECEIVED IN TWO FRAGMENT AND THE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS SCRAPPED CLOSED TO THE FRACTURE SITE. THERE WAS NO CLINICAL CONSEQUENCE TO THE PATIENT AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    956376 TRANSEND EX 014/205 FLOPPY WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 21630433 08714729326250

    Patients

    Seq Age Sex Outcome Treatment
    1