BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 054

    MDR report key: 2770463 · Received October 3, 2012

    Report

    Report Number
    3005168196-2012-00324
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    March 28, 2010
    Report Date
    April 5, 2010
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K090752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION CODE: VASOSPASM 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 "DEFINITE". EVAL SUMMARY: DEVICE NOT RETAINED BY HOSPITAL.

    Description of Event or Problem · 1

    ADDITIONAL FOLLOW-UP INFORMATION REVEALED THAT THIS PATIENT PASSED AWAY ON (B)(6), 2010. PATIENT DEATH CAUSED BY ICH. THE ICH WAS NOT RELATED TO THE STUDY DEVICE AND POSSIBLY RELATED TO THE PROCEDURE.THIS INFORMATION WAS ACCIDENTLY NOT INCLUDED IN THE ORIGINAL MDR.

    Description of Event or Problem · 1

    ORIGINAL INFORMATION PROVIDED ON (B)(6) 2010: (B)(6) (B)(4) HAD AN INTRACEREBRAL HEMORRHAGE ON (B)(6) 2010. FOLLOW UP IMAGING SHOWED 'THE PATIENT HAS BLED INTO THE DISTRIBUTION OF THE RIGHT MIDDLE CEREBRAL INFARCT. THIS IS CAUSING MASS EFFECT, DISPLACING THE VENTRICLES TO THE LEFT AND SLIGHTLY EFFACING THE BODY OF THE RIGHT LATERAL VENTRICLE. THE VENTRICLES ARE UNCHANGED IN OVERALL SIZE. NO OTHER AREAS OF HEMORRHAGE HAVE DEVELOPED. THERE ARE NO EXTRA-AXIAL FLUID COLLECTIONS.' FOLLOW-UP INFORMATION ON (B)(6) 2012 REVEALED THAT THIS EVENT WAS NOT RELATED TO THE PENUMBRA SYSTEM. HOWEVER, THE PATIENT ALSO HAD A VASOSPASM THAT WAS CONSIDERED DEFINITELY RELATED TO THE STUDY DEVICE. ADDITIONAL FOLLOW-UP INFORMATION REVEALED THAT THIS PATIENT PASSED AWAY ON (B)(6) 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other