BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 026

    MDR report key: 2143068 · Received June 23, 2011

    Report

    Report Number
    3005168196-2011-00265
    Event Type
    Injury
    Date Received
    June 23, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 25, 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 INFORMATION IN THIS REPORT WAS COLLECTED DURING THE REVIEW OF STROKE CASES FOR A (B)(4). THE INFORMATION AVAILABLE REGARDING THIS EVENT IS LIMITED TO THE PROCEDURAL REPORT PROVIDED BY THE HOSPITAL. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN OR QUALITY CONCERNS. DURING THE REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT, IT WAS NOTED THAT THE HOSPITAL USED THE CATHETER AFTER ITS LABELED USE BY DATE.

    Description of Event or Problem · 1

    DURING A STROKE PROCEDURE, THE PATIENT EXPERIENCED A VASOSPASM. THIS WAS TREATED WITH MEDICATION AND RESOLVED. THE SITE REPORTED THIS EVENT AS MILD IN SEVERITY, NOT SERIOUS, AND WITH AN UNCERTAIN RELATIONSHIP TO THE PENUMBRA SYSTEM. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2011-00263 THROUGH 3005169196-2011-00266.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 026 NRY PENUMBRA, INC. F12090

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention