BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX 014/205 FLOPPY

    MDR report key: 8011369 · Received October 28, 2018

    Report

    Report Number
    3008853977-2018-00059
    Event Type
    Malfunction
    Date Received
    October 28, 2018
    Date of Event
    October 7, 2018
    Report Date
    December 19, 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
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 BENT AT THE FRACTURE SITE. FROM THE CONDITION OF THE FRACTURE, FUNCTIONAL ANALYSIS WAS NOT BEING PERFORMED DUE TO THE ANOMALIES FOUND ON THE PRODUCT. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT NO ANOMALIES WERE NOTED TO THE GUIDEWIRE DURING THE INITIAL INSPECTION AND PREPARATION, THE DEVICE WAS PREPARED AS PER THE DEVICE DIRECTION FOR USE (DFU), CONTINUOUS FLUSH WAS MAINTAINED, THE BREAKAGE WAS NOTICED UPON REMOVAL FROM THE PATIENT, AND THE BROKEN PART WAS REMOVED SAFELY FROM THE PATIENT WITH THE MICROCATHETER AS ONE UNIT. ANALYSIS OF THE DEVICE REVEALED BENDING AT THE FRACTURE SITE WHICH IS AN INDICATION OF EXCESSIVE MANIPULATION DURING USE. FROM THE CONDITION OF THE FRACTURE, IT APPEARS THAT THE GUIDEWIRE KINKED AND THEN SEPARATED DUE TO HANDLING. THEREFORE, A PROBABLE CAUSE OF HANDLING DAMAGE HAS BEEN ASSIGNED TO THE AS REPORTED 'GUIDEWIRE BROKEN' AND THE AS ANALYZED ' GUIDEWIRE KINKED'. IT IS POSSIBLE THE PTFE COATING WAS DAMAGED DUE TO INSECURE TIGHTENING OF THE TORQUE DEVICE. HOWEVER, THIS COULD NOT BE DEFINITIVELY ASSESSED SINCE THE TORQUE DEVICE WAS NOT RETURNED FOR ANALYSIS. THEREFORE, A CAUSE OF UNDETERMINABLE HAS BEEN ASSIGNED TO THE AS ANALYZED 'NV - GUIDEWIRE PTFE COATING PEELING'.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SUBJECT DEVICE WAS BROKEN UPON REMOVAL. THE BROKEN PART WAS REMOVED SAFELY FROM THE PATIENT BODY WITH THE MICROCATHETER AS ONE UNIT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS UNAVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT SUBJECT DEVICE WAS BROKEN UPON REMOVAL. THE BROKEN PART WAS REMOVED SAFELY FROM THE PATIENT BODY WITH THE MICROCATHETER AS ONE UNIT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    852352 TRANSEND EX 014/205 FLOPPY WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 21983610 08714729326250

    Patients

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