BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 2091680 · Received May 3, 2011

    Report

    Report Number
    3005168196-2011-00199
    Event Type
    Injury
    Date Received
    May 3, 2011
    Date of Event
    September 8, 2009
    Report Date
    April 6, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: OCCLUSION IS A KNOWN AND ANTICIPATED COMPLICATION WITH THIS TYPE OF PROCEDURE AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE INFO IN THIS REPORT WAS COLLECTED DURING THE REVIEW OF STROKE CASES FOR A (B)(4). THE INFO AVAILABLE REGARDING THIS EVENT IS LIMITED TO THE PROCEDURAL REPORTS PROVIDED BY THE HOSPITAL.

    Description of Event or Problem · 1

    A PT PRESENTED TO THE HOSPITAL WITH AN ACUTE LEFT HEMISPHERIC STROKE (M1, MCA). AFTER USE OF THE PENUMBRA SYSTEM 032, THE ASPIRATION WAS TURNED OFF AND AN ARTERIOGRAM REVEALED REOCCLUSION OF THE DOMINANT DIVISION OF THE LEFT MIDDLE CEREBRAL ARTERY, WITH A TIMI 1 BLOOD FLOW. THE PENUMBRA CATHETER WAS THEN REMOVED AND A MICROCATHETER WAS THEN REPLACED AND 0.5 UNITS OF RETAVASE WERE ADMINISTERED WITH GUIDEWIRE MACERATION. FINALLY, THERE WAS COMPLETE REPERFUSION OF ALL BRANCHES OF THE LEFT MIDDLE CEREBRAL ARTERY, WITH TIMI 3 BLOOD FLOW, AND THE PROCEDURE WAS CONCLUDED. THE EVENT WAS REPORTED AS BEING POSSIBLY RELATED TO THE PENUMBRA SYSTEM AND ANGIOGRAPHIC PROCEDURE. THE EVENT WAS SEVERE, HOWEVER, IT WAS RESOLVED ON THE DAY OF THE PROCEDURE. THE PHYSICIAN STATED "THE RE-OCCLUSION OF THE VESSEL WAS 'POSSIBLY' RELATED TO THE PENUMBRA 32 CATHETER BECAUSE IT OCCURRED RIGHT AFTER I PLACED THE CATHETER IN THE VESSEL. THERE ARE SEVERAL POSSIBLE REASONS THE PENUMBRA CATHETER (OR ANY OTHER CATHETER) COULD HAVE CAUSED THE PROBLEM, INCLUDING SPASM OR JUST OBSTRUCTING THE FLOW MECHANICALLY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 032 NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention