BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENUMBRA SYSTEM SEPARATOR 032

    MDR report key: 2192906 · Received July 25, 2011

    Report

    Report Number
    3005168196-2011-00280
    Event Type
    Malfunction
    Date Received
    July 25, 2011
    Date of Event
    June 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: THIS DEVICE IS AVAILABLE FOR RETURN AND A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Description of Event or Problem · 1

    THE PATIENT HAD A MAJOR STROKE AND EMERGENCY MECHANICAL THROMBECTOMY PROCEDURE WAS PERFORMED. DUE TO PATIENT'S SEVERE TORTUOSITY IN BOTH THE PATIENT'S AORTIC ARCH AND INTERNAL CAROTID ARTERY, PASSING ANY MEDICAL DEVICES WAS EXTREMELY DIFFICULT. A PENUMBRA SYSTEM SEPARATOR 032 WAS ADVANCED THROUGH THIS EXCESSIVE TORTUOSITY AND ULTIMATELY KINKED AND BROKE OUTSIDE THE PATIENT'S BODY. ALL PARTS WERE REMOVED FROM THE PATIENT. TWO MORE SEPARATOR 032S WERE USED AND KINKED AND WERE REMOVED FROM THE PATIENT. ULTIMATELY A PENUMBRA SYSTEM REPERFUSION CATHETER 041 WAS CHOSEN TO ATTEMPT TO ADVANCE TO THE CLOT LOCATION. THE 041 CATHETER, UPON INSPECTION, WAS FOUND TO BE KINKED AND THEREFORE WAS NOT USED. A SECOND 041 CATHETER WAS OPENED AND SUCCESSFULLY ADVANCED TO THE CLOT LOCATION AND WAS SUCCESSFUL IN REMOVING THE CLOT. THE OUTCOME OF THE PROCEDURE WAS SUCCESSFUL WITH TIMI 2B REVASCULARIZATION. THIS MDR IS ASSOCIATED WITH MDRS 3005168196-2011-00279 THROUGH 3005169196-2011-00282.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1