BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 041

    MDR report key: 2080442 · Received April 22, 2011

    Report

    Report Number
    3005168196-2011-00179
    Event Type
    Injury
    Date Received
    April 22, 2011
    Date of Event
    January 25, 2011
    Report Date
    March 31, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: VASOSPASM 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)(6) (RETROSTART). THE INFO AVAILABLE REGARDING THIS EVENT IS LIMITED TO THE PROCEDURAL REPORTS PROVIDED BY THE HOSP. THE MFG RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    DURING THE PROCEDURE THE PT EXPERIENCED A VASOSPASM WHICH WAS REPORTED BY THE SITE TO BE POSSIBLY RELATED TO THE PENUMBRA SYSTEM AND PROBABLY RELATED TO THE ANGIOGRAPHIC PROCEDURE. THIS EVENT WAS REPORTED AS BEING MILD IN SEVERITY AND NOT SERIOUS. NO ACTION WAS TAKEN AND THE VASOSPASM RESOLVED. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2011-00177 AND 3004168196-2011-00178.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 041 NRY PENUMBRA, INC. F17294

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other