BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SEPARATOR 041

    MDR report key: 3233635 · Received July 18, 2013

    Report

    Report Number
    3005168196-2013-00287
    Event Type
    Injury
    Date Received
    July 18, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 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: DISSECTION OR PERFORATION ARE KNOWN AND ANTICIPATED COMPLICATIONS WITH THESE TYPES OF PROCEDURES AND ARE 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. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2013-00286. HOSPITAL DISCARDED OF DEVICE.

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING TREATMENT FOR MECHANICAL THROMBECTOMY. PSC041 WAS INTRODUCED WITH CHIKAI 14 NEUROVASCULAR GUIDE WIRE TO THE RIGHT ICA. ANGIOGRAPHY THEN REVEALED RADIOPAQUE DYE OOZING INTO THE CAVERNOUS SINUS. THE PATIENT WAS DIAGNOSED AS POSSIBLY GETTING A CAROTID-CAVERNOUS FISTULA. A SHORT TIME LATER ANOTHER ANGIOGRAPHY WAS DONE AND IT DID NOT PICTURE THE CCF. ASPIRATION WAS ATTEMPTED WITH PSC041 AGAIN BUT FAILED TO RECANALIZE. PHYSICIAN COMMENT: THE RELATIONSHIP OF THIS EVENT TO PSC041 IS UNCERTAIN, BUT THE RELATIONSHIP TO CHIKAI 14 NEUROVASCULAR GUIDE WIRE IS POSSIBLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334794 PENUMBRA SEPARATOR 041 NRY NRY PENUMBRA, INC. F24600

    Patients

    Seq Age Sex Outcome Treatment
    1 78 Other