BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM JETD REPERFUSION CATHETER

    MDR report key: 9712471 · Received February 14, 2020

    Report

    Report Number
    3005168196-2020-00178
    Event Type
    Injury
    Date Received
    February 14, 2020
    Date of Event
    July 2, 2019
    Report Date
    January 20, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548019741
    PMA / PMN Number
    K090752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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, VESSEL SPASM, INABILITY TO COMPLETELY REMOVE THROMBUS, HEMATOMA OR HEMORRHAGE AT ACCESS SITE, 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. ADDITIONAL 510(K)# THAT ALSO APPLIES TO THIS COMPLAINT: K133317.

    Description of Event or Problem · 1

    ON (B)(6) 2019, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM JETD REPERFUSION CATHETER (JETD), PENUMBRA SYSTEM 3MAX REPERFUSION CATHETER (3MAXC), AND NEURON MAX 6F 088 LONG SHEATH (NEURON MAX). DURING THE PROCEDURE, THE PHYSICIAN PLACED THE 3MAXC, JETD, AND NEURON MAX IN THE TARGET VESSEL AND USED THE JETD TO PERFORM ASPIRATION. A FOLLOW-UP ANGIOGRAM SHOWED RECANALIZATION OF OVER 50% OF THE OCCLUDED BRANCH. HOWEVER, MINIMAL CATHETER-INDUCED VASOSPASM WAS PRESENT. IT WAS NOT TREATED AS THE PATIENT SHOWED CONTINUED IMPROVEMENT. THE PHYSICIAN THEN ATTEMPTED TO CATHETERIZE THE OCCLUDED BRANCH, BUT THE PATIENT BEGAN TO EXPERIENCE EMESIS; THEREFORE, THE DEVICES WERE REMOVED. THE TWO EVENTS WERE CONSIDERED RESOLVED ON THE SAME DAY. THE PROCEDURE ENDED AT THIS POINT, AND A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) GRADE 2B RECANALIZATION WAS ACHIEVED. THE VASOSPASM WAS REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A DEFINITE RELATIONSHIP TO THE INDEX PROCEDURE AND JETD, AND THE EMESIS WAS REPORTED TO BE A NON-SERIOUS ADVERSE EVENT WITH A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE AND JETD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174692 PENUMBRA SYSTEM JETD REPERFUSION CATHETER NRY NRY PENUMBRA, INC. 5MAXJETDKIT-A F88770 00814548019741

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other