BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 054

    MDR report key: 2912334 · Received January 11, 2013

    Report

    Report Number
    3005168196-2013-00026
    Event Type
    Injury
    Date Received
    January 11, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 12, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. CONCLUSION: HEMORRHAGE IS A KNOWN AND ANTICIPATED COMPLICATION ASSOCIATED 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. DISCARDED BY HOSPITAL.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING TREATMENT FOR AN OCCLUSION IN THE M1. (HE HAD BEEN HOSPITALIZED BEFORE THE ONSET). NIHSS SCORE WAS 22 AND T-PA WAS ADMINISTRATED WITH NO RECANALIZATION CONFIRMED ON CT SCAN. FIRSTLY, THE MERCI CATHETER (2.5 SOFT) WAS USED WITH SLIGHT BLOOD CLOT RETRIEVED BUT NO RECANALIZATION, AND THEN THE PENUMBRA SYSTEM WAS USED. THE PSC054 WAS ADVANCED INTO THE M1 WITH FAILURE IN ASPIRATION DUE TO KICKBACK OF THE CATHETER. THE PSC032 WAS USED BUT FAILED IN INDUCING. THE SHEATH CONFIRMED STRETCHING WHEN CHECKED OUTSIDE OF THE PATIENT'S BODY. THE PHYSICIAN USED THE MERCI MICRO CATHETER NEXT WITH FAILURE IN INDUCING. CCF WAS REVEALED ON ANGIOGRAPHY. THE PSC054 FOUND STRETCHED WHEN CHECKED OUTSIDE OF THE PATIENT'S BODY. THE PATIENT WAS RECOVERING AS OF (B)(6) 2012. PHYSICIAN'S COMMENT: "IT'S DIFFICULT TO IDENTIFY WHEN THE PERFORATION OCCURRED BECAUSE ANGIOGRAPHY WAS NOT DONE IMMEDIATELY AFTER THE ASPIRATION WITH THE PSC054. FOR THE FACT THAT THE ANGIOGRAPHY FROM THE LT-IC ALL FLOWED INTO THE VEIN, THE POSSIBILITY THAT THE DEVICES INCLUDES THE PSC054 CAUSED THE CCF IS HIGH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18070 PENUMBRA SYSTEM REPERFUSION CATHETER 054 NRY NRY PENUMBRA, INC. F28001

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other