BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM REPERFUSION CATHETER 5MAX

    MDR report key: 2991294 · Received March 6, 2013

    Report

    Report Number
    3005168196-2013-00091
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    December 23, 2012
    Report Date
    February 7, 2013
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K113163
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: EMBOLI ARE A KNOWN AND ANTICIPATED COMPLICATION 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, QUALITY, OR DESIGN CONCERNS. THE INFORMATION IN THIS REPORT WAS REPORTED DURING REVIEW OF PATIENT DATA AS A PART OF THE PENUMBRA SEPARATOR 3D CLINICAL TRIAL. ALL INFORMATION AVAILABLE IS FROM PROCEDURAL REPORTS AND FOLLOW-UP WITH THE CLINICAL TRIAL COORDINATORS. DEVICE NOT RETAINED FOR RETURN.

    Description of Event or Problem · 1

    ON (B)(6) 2012 THE PATIENT WAS TREATED AS THE FIRST ROLL-IN CASE FOR SEPARATOR 3D IDE (CLP 4853) AT SITE #23-(B)(6) HOSPITAL. ONE PHYSICIAN PERFORMED THE PROCEDURE WHILE ANOTHER PHYSICIAN AND A PENUMBRA REPRESENTATIVE PRESENT. THE PENUMBRA REPRESENTATIVE COMMUNICATED TO PENUMBRA THAT NICARDIPINE HAD BEEN USED DUE TO A SUSPECTED VASOSPASM. THE PENUMBRA CLINICAL REPRESENTATIVE FOLLOWED UP THAT DAY WITH AN EMAIL ATTEMPTING TO CONFIRM. ON (B)(6) 2012, THE PHYSICIAN RESPONDED INDICATING THE SPASM WAS "DISTAL TO THE DEVICE, BUT IT DID NOT RESOLVE WITH NICARDIPINE, SUGGESTING IT WAS CLOT". ON (B)(6) 2013, THE PENUMBRA CLINICAL REPRESENTATIVE AGAIN FOLLOWED UP ATTEMPTING TO DISCERN FURTHER DETAILS REGARDING THE POTENTIAL EVENT. ON (B)(6) 2013 THE PENUMBRA CLINICAL REPRESENTATIVE SPOKE WITH THE PHYSICIAN ON THE PHONE AND DOCUMENTED THIS WITH AN EMAIL CONFIRMING THAT THE PHYSICIAN HAD CHANGED HIS CLASSIFICATION FROM "VASOSPASM" TO "DISTAL EMBOLI" AND ASKING FOR FURTHER CLARIFICATION REGARDING ITS RELATIONSHIP TO THE PENUMBRA SYSTEM AND SEPARATOR 3D. ON (B)(6) 2013, THE TRIAL RN RESPONDED WITH AN EMAIL TO THE PENUMBRA CLINICAL REPRESENTATIVE CLARIFYING THAT "[THE PHYSICIAN] REVIEWED THE ISSUE AND FEELS THAT ON THE FOLLOWUP MRI THE SMALL AREAS OF DIFFUSION ABNORMALITIES COULD BE ASCRIBED TO DISTAL EMBOLI BUT THEY ARE IN THE PRIMARY TERRITORY OF THE ORIGINAL OCCLUSION, THEREFORE, HE IS UNABLE TO KNOW IF THEY ARE FROM THE PRIMARY EVENT OR SECONDARY TO EMBOLI." AS WELL AS ATTACHING CRF 33, THE ADVERSE EVENT LOG, WHICH RULED THE EVENT AS HAVING "UNCERTAIN" RELATIONSHIP TO BOTH THE PENUMBRA SYSTEM AND SEPARATOR 3D. THIS MDR IS ASSOCIATED WITH MDR 3005168196-2013-00092

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95372 PENUMBRA SYSTEM REPERFUSION CATHETER 5MAX NRY NRY PENUMBRA, INC. F26596

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other