BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 032

    MDR report key: 2974150 · Received February 22, 2013

    Report

    Report Number
    3005168196-2013-00072
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    August 1, 2012
    Report Date
    February 6, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: VESSEL DISSECTION 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 MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. DEVICE DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT WAS UNDERGOING TREATMENT FOR ACUTE CEREBRAL INFARCTION. THE PHYSICIAN ADVANCED THE PSC054 WITH THE PSC032 AND THE GT WIRE INTO THE RIGHT ICA, AND THEN BEGAN ASPIRATION WHICH WAS SUCCESSFUL IN RECANALIZATION. NEXT, ANGIOGRAPHY FOR THE RIGHT MCA WAS CONDUCTED; HOWEVER, BECAUSE THE VESSEL CONTINUED TO APPEAR OCCLUDED, HE INDUCED THE PSC032 ALONG THE GT16 AND BEGAN ASPIRATION. AFTER THE ASPIRATION, ANGIOGRAPHY WAS CONDUCTED AND PERIPHERAL BRANCH OF THE RIGHT MCA WAS NOT PICTURED; THUS, UK WAS ADMINISTRATED INTRA-ARTERIALLY AND PROCEDURE WAS CONCLUDED. HEMORRHAGE IN THE RIGHT ICA, WAS CONFIRMED ON POSTOPERATIVE CT SCAN. PHYSICIAN'S COMMENT: "POSSIBILITY OF DISSECTION OCCURRENCE WAS POINTED ON ACCOUNT OF THE FALSE LUMEN APPEARANCE ON THE BLOOD VESSEL THE CATHETER PASSED THROUGH." THIS MDR IS ASSOCIATED WITH MDR 3005168196-2013-00070--00073.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78093 PENUMBRA SYSTEM REPERFUSION CATHETER 032 NRY NRY PENUMBRA, INC. F30043

    Patients

    Seq Age Sex Outcome Treatment
    1 Other