BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRANSEND EX 014/205 FLOPPY

    MDR report key: 8075990 · Received November 15, 2018

    Report

    Report Number
    3008853977-2018-00062
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 24, 2018
    Report Date
    January 4, 2019
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    UDI-DI
    08714729326250
    PMA / PMN Number
    K931584
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURING DATE: ADDED, DEVICE EVALUATED BY MFG: UPDATED, SUMMARY ATTACHED: UPDATED, EXPIRATION DATE: ADDED. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MICROCATHETER AND TORQUE DEVICE USED WITH THE GUIDEWIRE WERE NOT RETURNED. VISUAL INSPECTION REVEALED THAT THE GUIDEWIRE WAS RECEIVED IN TWO FRAGMENTS. MAGNIFIED EXAMINATION OF THE FRACTURE SITE SHOWED THE CORE WIRE WAS FRACTURED. THE GUIDEWIRE WAS BENT (KINKED) AT THE FRACTURE SITE AND THE GUIDEWIRE WAS ALSO BENT JUST PROXIMAL AND DISTAL TO THE FRACTURE SITE AS WELL. THE DEVICE WAS KINKED AT APPROXIMATELY 7.5CM FROM ITS DISTAL END AND BENT ALONG ITS POLYMER SLEEVE LENGTH. THE PTFE (POLYTETRAFLUOROETHYLENE) COATING WAS ALSO FOUND TO BE SCRAPED CLOSE TO THE FRACTURE SITE OF THE GUIDEWIRE. FUNCTIONAL TESTING COULD NOT BE PERFORMED DUE TO THE DAMAGED CONDITION OF THE RETURNED GUIDEWIRE. THE BENDING AND FRACTURE ON THE GUIDEWIRE APPEARED TO BE DUE TO EXCESSIVE MANIPULATION. INFORMATION AVAILABLE INDICATED THAT RESISTANCE WAS FELT WHEN PULLING THE WIRE OUT FROM THE DISPENSER HOOP AND THE WIRE SEPARATED FOLLOWING REMOVAL. ANALYSIS OF THE DEVICE REVEALED BENDING AT THE FRACTURE SITE WHICH IS AN INDICATION OF EXCESSIVE MANIPULATION. FROM THE CONDITION OF THE FRACTURE, IT APPEARS THAT THE GUIDEWIRE WAS KINKED, SCRAPED, AND THEN SEPARATED DUE TO EXCESSIVE FORCE APPLIED TO OVERCOME THE REPORTED RESISTANCE DURING REMOVAL FROM THE DISPENSER HOOP. 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 DURING PREPARATION FOR THE PROCEDURE, THE GUIDEWIRE WAS FOUND TO BE BROKEN ON THE PROXIMAL SECTION WHEN REMOVED FROM THE DISPENSER HOOP. THE PHYSICIAN REPLACED IT WITH A NEW GUIDEWIRE AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION FOR THE PROCEDURE, THE GUIDEWIRE WAS FOUND TO BE BROKEN ON THE PROXIMAL SECTION WHEN REMOVED FROM THE DISPENSER HOOP. THE PHYSICIAN REPLACED IT WITH A NEW GUIDEWIRE AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914808 TRANSEND EX 014/205 FLOPPY WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 21068005 08714729326250

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR