BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JET 7 THROMBECTOMY CATHETER

    MDR report key: 10605947 · Received September 29, 2020

    Report

    Report Number
    MW5096955
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Date of Event
    September 1, 2020
    Report Date
    September 25, 2020
    Manufacturer
    PENUMBRA INC.
    Product Code
    NRY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OR, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE CATHETER BEGAN TO UNRAVEL AT THE DISTAL TIP OF THE CATHETER WITH THE WIRE REINFORCEMENT ENTERING THE CAROTID VESSEL. THE COILED WIRE WAS NOTICED ON FLUOROSCOPY AND THE PHYSICIAN IMMEDIATELY REMOVED THE DAMAGED CATHETER FROM THE PATIENT'S VESSEL. DR Z EVALUATED THE PATIENT FOR INJURY, NONE WAS FOUND. THE CATHETER WAS INSPECTED IMMEDIATELY AND DETERMINED THAT IT HAD BECOME UNUSABLE. IMAGES WERE TAKEN OF THE DAMAGED CATHETER. A NEW CATHETER WAS UTILIZED TO COMPLETE THE PROCEDURE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065751 JET 7 THROMBECTOMY CATHETER CATHETER, THROMBUS RETRIEVER NRY PENUMBRA INC. 5MAXJET7KIT F95385

    Patients

    Seq Age Sex Outcome Treatment
    1