BEUDAMED
    FDA Adverse Event Other Summary report: N

    PENUMBRA SYSTEM SEPARATOR 041

    MDR report key: 1853233 · Received September 29, 2010

    Report

    Report Number
    3005168196-2010-00650
    Event Type
    Other
    Date Received
    September 29, 2010
    Date of Event
    August 31, 2010
    Report Date
    September 3, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT DID NOT RETURN FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE INFORMATION IN THIS REPORT WAS COLLECTED AS A PART OF THE PENUMBRA (B)(4). THE CASE REPORT INDICATED THAT THE CLINICAL EVENT OCCURRED IMMEDIATELY FOLLOWING TREATMENT WITH THE PENUMBRA SYSTEM 041 HOWEVER, THERE WAS NO INDICATION THAT THERE WAS ANY ISSUE RELATED TO THE DEVICE(S).

    Description of Event or Problem · 1

    THE PATIENT WAS TREATED FOR A STROKE USING THE PENUMBRA SYSTEM 041 AND EXPERIENCED A BRIEF EPISODE OF HYPOTENSION AFTER ARRIVAL TO THE NSICU WITH WORSENING EXAM HOWEVER, THIS IMPROVED RAPIDLY WITH A FLUID BOLUS AND NORMALIZATION OF BLOOD PRESSURE. THIS EVENT WAS REPORTED AS POSSIBLY RELATED TO THE PENUMBRA SYSTEM BECAUSE, THE HYPOTENSION WAS DISCOVERED AS HE ARRIVED IN THE ICU FROM THE VASCULAR INTERVENTIONAL SUITE. IT WAS NOTED THAT THE EVENT MAY HAVE BEEN PROCEDURE RELATED HOWEVER, THE HOSPITAL FELT THERE WAS NO WAY TO TELL. THERE WERE NO TESTS PERFORMED AND NO OTHER INTERVENTION. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2010-00649.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 041 PERCUTANEOUS CATHETER NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention