BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND EX 014/205 SOFT TIP

    MDR report key: 6979770 · Received October 26, 2017

    Report

    Report Number
    3008853977-2017-00043
    Event Type
    Injury
    Date Received
    October 26, 2017
    Date of Event
    September 27, 2017
    Report Date
    December 27, 2017
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K934122
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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. THE GUIDEWIRE WAS RETURNED IN TWO FRAGMENTS, WRAPPED AROUND ITSELF. VISUAL AND MICROSCOPIC INSPECTION OF THE DEVICE NOTED THE PROXIMAL FRAGMENT WAS APPROXIMATELY 80.4CM IN LENGTH AND THE DISTAL FRAGMENT WAS APPROXIMATELY 123.3CM IN LENGTH; THE GUIDEWIRE WAS SHAPED ON ITS DISTAL SECTION. ADDITIONALLY, THE GUIDEWIRE POLYTETRAFLUOROETHYLENE (PTFE) COATING WAS EXAMINED AND WAS FOUND SCRAPED APPROXIMATELY 21.0CM FROM ITS PROXIMAL END, HOWEVER A DEFINITE CAUSE COULD NOT BE DETERMINED. MAGNIFIED EXAMINATION OF THE FRACTURE SITE SHOWED THE CORE WIRE WAS FRACTURED. THE GUIDEWIRE WAS BENT AT THE FRACTURE SITE, AND JUST DISTAL AND PROXIMAL TO THE FRACTURE SITE, AND BENT AND KINKED ALONG ITS POLY SLEEVE LENGTH. FROM THE CONDITION OF THE GUIDEWIRE AT THE FRACTURE SITE, THE BENDING AND FRACTURE ON THE GUIDEWIRE APPEARED TO BE DUE TO EXCESSIVE MANIPULATION. THE DEVICE DIRECTIONS FOR USE (DFU) STATES ¿EXERCISE CARE IN HANDLING A GUIDEWIRE DURING A PROCEDURE TO REDUCE THE POSSIBILITY OF ACCIDENTAL BREAKAGE, BENDING OR KINKING.¿ BASED ON INVESTIGATION RESULTS AND AVAILABLE INFORMATION, AN ASSIGNABLE CAUSE OF USER ERROR WAS ASSIGNED.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL END OF THE GUIDEWIRE BROKE DURING MANIPULATION. THE PHYSICIAN USED A MICRO SNARE TO REMOVE THE BROKEN DISTAL END FROM THE PATIENT'S BODY. THE PROCEDURE CONTINUED WITH ANOTHER OF THE SAME DEVICE WITHOUT CLINICAL CONSEQUENCE TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL END OF THE GUIDEWIRE BROKE DURING MANIPULATION. THE PHYSICIAN USED A MICRO SNARE TO REMOVE THE BROKEN DISTAL END FROM THE PATIENT'S BODY. THE PROCEDURE CONTINUED WITH ANOTHER OF THE SAME DEVICE WITHOUT CLINICAL CONSEQUENCE TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760411 TRANSEND EX 014/205 SOFT TIP WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 19414283

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention EXCELSIOR MICROCATHETER (STRYKER)