BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MARKSMAN CATHETER

    MDR report key: 11847898 · Received May 18, 2021

    Report

    Report Number
    MW5101409
    Event Type
    Malfunction
    Date Received
    May 18, 2021
    Date of Event
    May 10, 2021
    Report Date
    May 14, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
    Product Code
    KRA
    UDI-DI
    00847536026261
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT PRESENTED TO THE ED AS STROKE ALERT. A BRAIN CT PERFORMED, AND DECISION MADE TO DO EMERGENT CEREBRAL ANGIOGRAM WITH POSSIBLE THROMBECTOMY. DURING PROCEDURE WHILE PULLING OUT THE CATHETER, THE TIP OF THE CATHETER BROKE OFF AND WAS RETAINED IN THE DISTAL CORTICAL BRANCH. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741705 MARKSMAN CATHETER CATHETER, CONTINUOUS FLUSH KRA MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR FA-55150-1030 220229485 00847536026261

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other