BEUDAMED
    FDA Adverse Event Other Summary report: N

    PENUMBRA SYSTEM

    MDR report key: 1740698 · Received June 25, 2010

    Report

    Report Number
    3005168196-2010-00514
    Event Type
    Other
    Date Received
    June 25, 2010
    Date of Event
    March 5, 2010
    Report Date
    March 12, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PHYSICIANS ON THE CASE NOTED THAT THERE WAS NO VESSEL INJURY DUE TO THE DEVICE HOWEVER, THERE IS NO WAY TO RULE OUT ALL CAUSES OF HEMORRHAGE. ADDITIONAL INFORMATION: (B)(6) 2010. ADDITIONAL INFORMATION: (B)(4) 2010. ADDITIONAL INFORMATION: (B)(4) 2010.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT MECHANICAL THROMBECTOMY WITH THE PENUMBRA SYSTEM ON (B)(6) 2010. ON (B)(6) 2010, THE PATIENT DEVELOPED A HEMORRHAGE THAT LASTED UNTIL (B)(6) 2010. THE HEMORRHAGE WAS A NON-SERIOUS ADVERSE EVENT, WITH AN UNCERTAIN RELATIONSHIP TO THE PENUMBRA SYSTEM AND ANGIOGRAPHIC PROCEDURE. ON (B)(6) 2010, THE PATIENT DEVELOPED A SEPARATE SUBARACHNOID HEMORRHAGE, WHICH ALSO RESOLVED AS OF (B)(6) 2010. THE SAH WAS UNRELATED TO THE PENUMBRA SYSTEM AND THE ANGIOGRAPHIC PROCEDURE. AS OF (B)(6) 2010, THERE WAS NO ADDITIONAL INFORMATION. HOWEVER, BY (B)(6) 2010, THE PHYSICIAN DETERMINED THAT IT IS NOT POSSIBLE TO DETERMINE RELATIONSHIP TO DEVICE IN THIS CASE.

    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