BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM JETD REPERFUSION CATHETER

    MDR report key: 8489366 · Received April 5, 2019

    Report

    Report Number
    3005168196-2019-00647
    Event Type
    Injury
    Date Received
    April 5, 2019
    Date of Event
    October 26, 2018
    Report Date
    March 7, 2019
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548019741
    PMA / PMN Number
    K090752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE NOT REFERENCED ON THE INITIAL MFR REPORT AND ARE BEING ADDRESSED ON THIS FOLLOW-UP #01 MFR REPORT: 3005168196-2019-00647 THE PRODUCT WAS NOT RETURNED FOR EVALUATION. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. POTENTIAL ADVERSE EVENTS IN THE LABELING WITH THE PENUMBRA SYSTEM INCLUDE, BUT ARE NOT LIMITED TO, HEMATOMA OR HEMORRHAGE AT THE SITE, INABILITY TO COMPLETELY REMOVE THROMBUS, INTRACRANIAL HEMORRHAGE, ISCHEMIA, INCLUDING DEATH. THEREFORE, IT WAS DETERMINED THAT THE REPORTED ADVERSE EVENTS WERE ANTICIPATED COMPLICATIONS. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2019-00648.

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K) # THAT ALSO APPLY TO THIS COMPLAINT: K133317. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2019-00648.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE MIDDLE CEREBRAL ARTERY USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD) AND A PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC) ON (B)(6) 2018. ON (B)(6) 2018, THE PATIENT EXPERIENCED AN ASYMPTOMATIC HI-1 SMALL PETECHIAL HEMORRHAGE IN THE LEFT INSULA. THIS EVENT WAS NOT CONSIDERED A SERIOUS ADVERSE EVENT. THIS EVENT WAS ADJUDICATED TO BE RELATED TO PENUMBRA CATHETERS, POSSIBLY RELATED TO THE JETD AND A 3MAXC, AND POSSIBLY RELATED TO THE INDEX PROCEDURE. NO ADDITIONAL TREATMENT WAS DONE, AND THIS EVENT WAS CONSIDERED RESOLVED AS OF (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279499 PENUMBRA SYSTEM JETD REPERFUSION CATHETER NRY NRY PENUMBRA, INC. F82291 00814548019741

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization