BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM 5MAX SEPARATOR

    MDR report key: 3051486 · Received April 10, 2013

    Report

    Report Number
    3005168196-2013-00134
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    February 11, 2013
    Report Date
    March 11, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K113163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: HEMORRHAGE IS A KNOWN AND ANTICIPATED COMPLICATION WITH THESE TYPES OF PROCEDURES AND IS NOTED IN THE DEVICE LABELING. THEREFORE, IT WAS DETERMINED THAT THE REPORTED EVENT WAS AN ANTICIPATED PROCEDURAL COMPLICATION. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. THIS CASE IS RELATED TO 3005168196-2013-00135, AND 3005168196-2013-00136. HOSPITAL DISCARDED DEVICE.

    Description of Event or Problem · 1

    IMAGING DEMONSTRATED A LEFT INTERNAL CAROTID ARTERY OCCLUSION IN PATIENT. PATIENT WAS SCREENED, CONSENTED AND RANDOMIZED INTO THE (B)(4). PATIENT WAS RANDOMIZED TO THE PENUMBRA SYSTEM ARM OF THE TRIAL. THE PHYSICIAN MADE FOUR PASSES WITH THE 5MAX SEPARATOR AND CATHETER AFTER WHICH THERE WAS STILL EVIDENCE OF PERSISTENT OCCLUSION AT THE CAROTID TERMINUS. ONE PASS WAS THEN MADE WITH A SOLITAIRE DEVICE AFTER WHICH THE PHYSICIAN NOTED SOME EXTRAVASATION AND MADE THE DECISION TO TERMINATE THE PROCEDURE. IT WAS LATER DETERMINED THAT THE PATIENT SUFFERED A SUBARACHNOID HEMORRHAGE THAT WAS DETERMINED TO BE OF "POSSIBLE" RELATIONSHIP TO THE PENUMBRA SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150021 PENUMBRA SYSTEM 5MAX SEPARATOR NRY NRY PENUMBRA, INC. F28069

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Life Threatening