BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND EX 014/205 FLOPPY

    MDR report key: 6739190 · Received July 24, 2017

    Report

    Report Number
    3008853977-2017-00012
    Event Type
    Injury
    Date Received
    July 24, 2017
    Date of Event
    June 26, 2017
    Report Date
    September 25, 2017
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K944677
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. DURING THE ANALYSIS OF THE RETURNED DEVICE, IT WAS REVEALED THAT THE GUIDEWIRE WAS BROKEN IN TWO FRAGMENTS AND THE PTFE (POLYTETRAFLUOROETHYLENE) WAS SCRAPPED OFF VERY CLOSE TO THE SEPARATED SITE. IN ADDITION, IT WAS REVEALED THAT THE GUIDEWIRE WAS SEVERELY BENT AND KINKED AT SEVERAL PLACES ALONG ITS PTFE LENGTH AND ALONG ITS POLYSLEEVE LENGTH DUE TO EXCESSIVE MANIPULATION. FUNCTIONAL ANALYSIS COULD NOT BE PERFORMED DUE TO THE ANOMALIES FOUND ON THE PRODUCT. THERE WAS NECKING AT THE FRACTURE SITE WHICH COULD INDICATE A DUCTILE FRACTURE CAUSED BY BENDING AND TWISTING OF THE COREWIRE. FURTHERMORE, PER THE DFU: ¿EXERCISE CARE IN HANDLING A GUIDE WIRE DURING A PROCEDURE TO REDUCE THE POSSIBILITY OF ACCIDENTAL BREAKAGE, BENDING OR KINKING. EXCESSIVE TIGHTENING OF THE TORQUE DEVICE ONTO THE WIRE MAY RESULT IN ABRASION OF THE COATING OF THE WIRE.¿ THEREFORE A CAUSE OF USE ERROR WAS ASSIGNED TO THE GUIDEWIRE BROKEN AND GUIDEWIRE PTFE COATING PEELING.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, IT WAS REPORTED THAT THE LAST 3CM OF THE GUIDEWIRE (SUBJECT DEVICE) BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN HAD TO GO IN WITH THE NON STRYKER DEVICE AND RETRIEVED THE BROKEN WIRE. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

    Description of Event or Problem · 1

    DURING THE PROCEDURE, IT WAS REPORTED THAT THE LAST 3CM OF THE GUIDEWIRE (SUBJECT DEVICE) BROKE OFF INSIDE THE PATIENT. THE PHYSICIAN HAD TO GO IN WITH THE NON STRYKER DEVICE AND RETRIEVED THE BROKEN WIRE. NO CLINICAL CONSEQUENCES REPORTED TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518796 TRANSEND EX 014/205 FLOPPY WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention