BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER

    MDR report key: 3828221 · Received May 22, 2014

    Report

    Report Number
    3005168196-2014-00325
    Event Type
    Injury
    Date Received
    May 22, 2014
    Date of Event
    December 21, 2013
    Report Date
    April 24, 2014
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K113163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: 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, DESIGN, OR QUALITY CONCERNS. DEVICE WAS DISPOSED OF BY THE HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE FROM THE LEFT INTERNAL CAROTID ARTERY (ICA, C1) TO THE LEFT MIDDLE CEREBRAL ARTERY (MCA, M1) USING THE PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER. BEFORE THE PROCEDURE, THE PATIENT WAS GIVEN 27,120,000 UNITS OF INTRAVENOUS TISSUE PLASMINOGEN (IV T-PA). DURING THE PROCEDURE, A 5MAX REPERFUSION CATHETER WAS ADVANCED TO THE C1 ALONG WITH A CHIKAI 0.014 INCH THROUGH AN OPTIMO GUIDE CATHETER 9F. ASPIRATION WAS CONDUCTED WITH A 3MAX SEPARATOR, AND IN THE M1 WITH THE 5MAX REPERFUSION CATHETER AND A 4MAX REPERFUSION CATHETER. THE PATIENT WAS THEN GIVEN 5000 UNITS OF HEPARIN THROUGH INJECTION. THE MANIPULATION OF THE 4MAX REPERFUSION CATHETER CAUSED DISSECTION IN THE M2. ANGIOGRAPHY SHOWED THAT RADIOPAQUE DYE ACCUMULATED ON THE WALLS OF THE ARTERY. THERE WAS NO OCCLUSION OR HEMORRHAGE. THE PHYSICIAN CLOSELY MONITORED THE PATIENT'S CONDITION BUT WITHHELD TREATMENT. APPROXIMATELY ONE MONTH AFTER THE PROCEDURE, THE PATIENT LEFT THE HOSPITAL AND AS OF (B)(6) 2014, 90 DAYS AFTER THE OPERATION, THE PATIENT'S MODIFIED RANKING SCORE (MRS) SCORE WAS 3 (MODERATE DISABILITY, BUT CAN WALK). PHYSICIAN'S COMMENT: I OBSERVED THROUGH ANGIOGRAPHY THAT I DISSECTED THE ARTERY DURING ASPIRATION ATTACHING THE 4MAX REPERFUSION CATHETER TO THE CLOT. THE EVENT WAS RELATED TO THE PENUMBRA SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305900 PENUMBRA SYSTEM 4MAX REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F33783

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Other