BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 041

    MDR report key: 2770531 · Received October 3, 2012

    Report

    Report Number
    3005168196-2012-00346
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    February 8, 2011
    Report Date
    June 4, 2012
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K072718
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: HEMORRHAGE 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. AS THIS PATIENT WAS ENROLLED IN THE POST-MARKET STUDY, (B)(6), THE EVENT WAS NOT DISCOVERED UNTIL LATER DATA COLLECTION AND THE SPONSOR REVIEWED THE FINAL DATA ENTRY DISCREPANCIES DURING STUDY CLOSE OUT. FINAL CLARIFICATION OF THE EVENT AND RELATIONSHIP TO THE SYSTEM WAS EVALUATED AND THE RELATIONSHIP TO THE DEVICE REMAINS "POSSIBLE". THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, QUALITY, OR DESIGN CONCERNS. EVAL SUMMARY: DEVICE NOT RETAINED BY HOSPITAL.

    Description of Event or Problem · 1

    ON (B)(6) 2011, PATIENT WAS UP AT 5:30 GETTING READY FOR WORK. PATIENT FELL BETWEEN 6 OR 6:15 IN THE BATHROOM AND WAS UNABLE TO GET UP. PATIENT PRESENTED TO THE HOSPITAL AT 07:52 ON THE SAME DATE. PATIENT WAS IDENTIFIED WITH AN ACUTE STROKE WITH RIGHT HEMISPLEGIA, DYSARTHRIA WITH NIH OF 16 AND EVIDENCE OF LEFT M1 OCCLUSION. PATIENT WAS TREATED IN 2-1/2 HOUR FROM SYMPTOM WITH IV-TPA WITH NO IMPROVEMENT AND WAS TAKEN FOR AN ENDOVASCULAR OPTION. THE PATIENT WAS TREATED WITH THE PENUMBRA 041 WITH A SEPARATOR. REVASCULARIZATION WAS ACHIEVED SUCCESSFULLY WITH NO PROCEDURAL COMPLICATION. ON (B)(6) 2011, PATIENT WAS DIAGNOSED WITH PETECHIAL HEMORRHAGE. THE EVENT WAS REPORTED AS MODERATE, NOT SERIOUS, WITH POSSIBLE RELATIONSHIP TO THE STUDY DEVICE AND ANGIOGRAPHIC PROCEDURE. THIS RESOLVED ON (B)(6) 2011 WITHOUT ANY ACTION TAKEN. THE EVENT WAS ENTERED INTO THE (B)(4) BY THE SITE ON (B)(6) 2012. THE PENUMBRA CLINICAL DEPARTMENT BECAME AWARE OF THIS EVENT ON (B)(4) 2012 WHILE PERFORMING AN INTERNAL RECONCILIATION OF EVENTS FOR THIS TRIAL. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2012-00347.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PENUMBRA SYSTEM REPERFUSION CATHETER 041 NRY NRY PENUMBRA, INC. F18949

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other