BEUDAMED
    FDA Adverse Event Death Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 2874214 · Received December 14, 2012

    Report

    Report Number
    3005168196-2012-00428
    Event Type
    Death
    Date Received
    December 14, 2012
    Date of Event
    November 14, 2012
    Report Date
    November 14, 2012
    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 PERFORATION 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 PHYSICIAN PERFORMED THROMBECTOMY ON THE PATIENT WITH ACUTE CEREBRAL INFARCTION IN THE LEFT MCA (M2). A GUIDING CATHETER WAS INTRODUCED INTO THE ICA FROM THE BRACHIAL A. THE SL-10 AND THE CHIKAI 200 WIRE WERE USED TO PENETRATE THE OCCLUSION PART AND AN ANGIOGRAPHY FOLLOWED. THE PHYSICIAN INSERTED THE CHIKAI 300 AND REPLACED THE CATHETER TO THE PSC032. THE PHYSICIAN FELT THE MOTION OF THE PSS032 WAS STRANGE FROM THE WAY IT HAD BEEN WHEN INSERTING, AND CONDUCTED ANGIOGRAPHY AND NOTED EXTRAVASATION. THE GATEWAY (2.5X12) BALLOON WAS ADVANCED TO ARREST THE HEMORRHAGE AND HAD INFLATED FOR THREE TIMES IN FIVE MINUTES. THIS WAS NOT SUCCESSFUL THEREFORE, FOUR ED COILS, FOUR TARGET COILS, AND FOUR TORNADO COILS WERE PLACED AS ADDITIONAL TREATMENT AND THE PROCEDURE WAS CONCLUDED. THE PSS032 MOVED UNEASILY COMPARED TO THE GUIDE WIRE. IT IS THOUGHT OF POSSIBLE THAT THE PSS032 PERFORATED THE BLOOD VESSEL DUE TO THE EXTRAVASATION REVEALED BY THE FOLLOWING ANGIOGRAPHY. FOLLOW-UP INFORMATION ON (B)(6) 2012: THE PATIENT DIED ON (B)(6) 2012. THE PHYSICIAN CONSIDERS SAH OR INFARCTION MAY HAVE CAUSED THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM SEPARATOR 032 NRY NRY PENUMBRA, INC. F25958

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R