BEUDAMED
    FDA Adverse Event Other Summary report: N

    PENUMBRA SYSTEM

    MDR report key: 1981359 · Received February 3, 2011

    Report

    Report Number
    3005168196-2011-00018
    Event Type
    Other
    Date Received
    February 3, 2011
    Date of Event
    July 11, 2010
    Report Date
    January 4, 2011
    Manufacturer
    PENUMBRA INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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 INFO PROVIDED IN THIS COMPLAINT WAS DISCOVERED DURING A REVIEW OF DATA COLLECTED DURING A PENUMBRA POST-MARKET CLINICAL TRIAL. THE HOSPITAL USED MULTIPLE SIZES OF THE PENUMBRA SYSTEM AND ARE NOT ABLE TO SPECIFICALLY POINT TO ANY ONE DEVICE AS THE CAUSE OF THE EVENT. THERE WAS NO DEVICE MALFUNCTION ASSOCIATED WITH THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS TREATED FOR A STROKE AND DEVELOPED A SUBARACHNOID BLEED ONE DAY POST-TREATMENT. THIS EVENT WAS REPORTED BY THE SITE TO BE MILD IN SEVERITY, POSSIBLY RELATED TO THE STUDY DEVICE AND THE ANGIOGRAPHIC PROCEDURE, AND WAS UNRESOLVED AT THE TIME. THE EVENT WAS ALSO REPORTED AS NOT SERIOUS AND NO ACTION WAS TAKEN AS A RESULT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other