BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 2121073 · Received June 9, 2011

    Report

    Report Number
    3005168196-2011-00246
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    October 12, 2010
    Report Date
    May 12, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: HEMORRHAGE 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

    ON THE NIGHT OF (B)(6) 2010, THE PT WAS FOUND SLUMPED IN CHAIR, WITH SYMPTOMS OF ACUTE ISCHEMIC STROKE INCLUDING APHASIA, RIGHT SIDED WEAKNESS AND RIGHT FACIAL DROOP. THE PT PRESENTED TO THE HOSPITAL THE MORNING OF (B)(6) 2010 AND WAS TREATED FOR AN OCCLUSION IN THE LEFT M2. THE PENUMBRA SYSTEM REPERFUSION CATHETER 032 WAS USED TO ASPIRATE AT THIS TARGET VESSEL, AND PERSISTENT OCCLUSIONS IN THE A2 WERE TREATED WITH MECHANICAL AGITATION WITH THE MICROGUIDEWIRE. THE PENUMBRA SYSTEM SEPARATOR 032 WAS ALSO USED TO TREAT AN OCCLUSION IN THE MCA. POST-PROCEDURE CT SCANS REVEALED A PETECHIAL HEMORRHAGE, WHICH WAS REPORTED DURING A REVIEW OF THE CLINICAL REPORT WITH POSSIBLE RELATIONSHIP TO THE STUDY DEVICE AND PROBABLE RELATIONSHIP TO THE ANGIOGRAPHIC PROCEDURE. THE EVENT WAS UNRESOLVED, BUT NOT REPORTED AS SERIOUS. ON (B)(6) 2011, THE COORDINATOR WAS CONTACTED BY PHONE, BUT SHE SAID, SHE COULD NOT OBTAIN ANY CLARIFICATION ON THE POSSIBLE NATURE OF THE RELATIONSHIP BETWEEN THE EVENT AND THE DEVICE. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2011-00250.

    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 72 YR