BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENROUTE,ST,MOD,S,HY,US 95-014

    MDR report key: 13422736 · Received February 2, 2022

    Report

    Report Number
    3006010712-2022-00002
    Event Type
    Malfunction
    Date Received
    February 2, 2022
    Date of Event
    January 12, 2022
    Report Date
    March 16, 2022
    Manufacturer
    BRIVANT LTD. T/A LAKE REGION MEDICAL
    Product Code
    DQX
    PMA / PMN Number
    K160643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION HAS BEEN COMPLETED AND THE INVESTIGATION RESULTS RECORDS ARE ATTACHED TO THIS REPORT.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT INVESTIGATION UNDERWAY AND WILL BE ATTACHED TO THIS REPORT.

    Description of Event or Problem · 0

    DURING A TCAR PROCEDURE, AFTER NPS PLACEMENT AND MULTIPLE FAILED ATTEMPTS TO ADVANCE BOTH THE .035" J-WIRE AND 0.014" GUIDEWIRE THROUGH A TIGHTLY STENOSED LESION, EXTRAVASATION WITH DIMINISHED FLOW WAS OBSERVED IN DISTAL ICA. THE PHYSICIAN ELECTED TO CONVERT THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA).

    Description of Event or Problem · 0

    DURING A TCAR PROCEDURE, AFTER NPS PLACEMENT AND MULTIPLE FAILED ATTEMPTS TO ADVANCE BOTH THE .035" J-WIRE AND 0.014" GUIDEWIRE THROUGH A TIGHTLY STENOSED LESION, EXTRAVASATION WITH DIMINISHED FLOW WAS OBSERVED IN DISTAL ICA. THE PHYSICIAN ELECTED TO CONVERT THE PROCEDURE TO A CAROTID ENDARTERECTOMY (CEA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1386538 ENROUTE,ST,MOD,S,HY,US 95-014 ENROUTE,ST,MOD,S,HY,US 95-014 DQX BRIVANT LTD. T/A LAKE REGION MEDICAL 901047-01 6150255

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other