BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSEND EX 014/205 FLOPPY

    MDR report key: 5331132 · Received December 28, 2015

    Report

    Report Number
    3008853977-2015-00544
    Event Type
    Injury
    Date Received
    December 28, 2015
    Date of Event
    December 1, 2015
    Report Date
    December 3, 2015
    Manufacturer
    BOSTON SCIENTIFIC COSTA RICA
    Product Code
    DQX
    PMA / PMN Number
    K944677
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    FDA MEDWATCH PROGRAM NUMBER: MW5058362. EVENT DATE: CORRECTED. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE ANALYSIS CANNOT BE PERFORMED AND AN ASSIGNABLE CAUSE WAS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE (SUBJECT DEVICE) BROKE OFF INSIDE THE ILIAC ARTERY OF THE PATIENT. THE PHYSICIAN WAS ABLE TO REMOVE THE BROKEN PIECE OF THE GUIDEWIRE WITH A UNSPECIFIED TYPE OF SNARE DEVICE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE GUIDEWIRE (SUBJECT DEVICE) BROKE OFF INSIDE THE ILIAC ARTERY OF THE PATIENT. THE PHYSICIAN WAS ABLE TO REMOVE THE BROKEN PIECE OF THE GUIDEWIRE WITH A UNSPECIFIED TYPE OF SNARE DEVICE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    854588 TRANSEND EX 014/205 FLOPPY WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC COSTA RICA 17830402

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention