BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND EX 014/205 PLATINUM

    MDR report key: 8303424 · Received February 4, 2019

    Report

    Report Number
    3008853977-2019-00014
    Event Type
    Injury
    Date Received
    February 4, 2019
    Date of Event
    January 15, 2019
    Report Date
    April 5, 2019
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    UDI-DI
    08714729326267
    PMA / PMN Number
    K971254
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE AND IT WAS OBSERVED THAT THE GUIDEWIRE WAS RECEIVED IN TWO FRAGMENTS; THE GUIDEWIRE WAS BENT AT THE FRACTURE SITE AND THE PLATINUM COIL WAS STRETCHED. FUNCTIONAL COULD NOT BE PERFORMED BASED ON DAMAGE TO PRODUCT. FROM THE CONDITION OF THE GUIDEWIRE AT THE FRACTURE SITE, IT APPEARS THAT THE GUIDEWIRE MAY HAVE SEPARATED DUE TO OVER TORQUEING AND BENDING, WHICH MAY HAVE OCCURRED DUE TO EXCESSIVE MANIPULATION OF THE GUIDEWIRE THROUGH THE MODERATELY TORTUOUS ANATOMY. IT IS LIKELY THAT THE KINK OBSERVED AT THE PROXIMAL SECTION DURING THE PRODUCT ANALYSIS WAS ALSO CAUSED DUE TO EXCESSIVE MANIPULATION AND TORQUEING OF THE GUIDEWIRE. THE REPORTED EVENT WAS CONFIRMED BASED ON THE PRODUCT ANALYSIS. IT IS PROBABLE THAT THE DEVICE WAS DAMAGED DURING THE CLINICAL PROCEDURE DUE TO SOME PROCEDURAL/ANATOMICAL FACTORS ENCOUNTERED CAUSING THE AS REPORTED EVENT, THEREFORE ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO REPORTED ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PROCEDURE, THE TIP OF THE GUIDEWIRE BROKE OFF INSIDE PATIENT IN THE CAROTID ARTERY AND HAD TO BE RETRIEVED WITH A SNARE DEVICE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PROCEDURE, THE TIP OF THE GUIDEWIRE BROKE OFF INSIDE PATIENT IN THE CAROTID ARTERY AND HAD TO BE RETRIEVED WITH A SNARE DEVICE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95706 TRANSEND EX 014/205 PLATINUM WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 22553066 08714729326267

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VELOCITY MICROCATHETER (PENUMBRA)