BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER

    MDR report key: 11767936 · Received May 4, 2021

    Report

    Report Number
    3005168196-2021-00931
    Event Type
    Injury
    Date Received
    May 4, 2021
    Date of Event
    October 9, 2020
    Report Date
    April 6, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    UDI-DI
    00814548017433
    PMA / PMN Number
    K160449
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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, INTRACRANIAL HEMORRHAGE, HEMATOMA OR HEMORRHAGE AT THE SITE, VESSEL SPASM, DISTAL EMBOLIZATION, DISSECTION, INABILITY TO COMPLETELY REMOVE THROMBUS, THROMBOSIS, ISCHEMIA, INCLUDING DEATH. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS.

    Description of Event or Problem · 1

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA) USING A PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER (ACE60), A NON-PENUMBRA GUIDE CATHETER, AND A STENT RETRIEVER. DURING THE PROCEDURE, THE PHYSICIAN MADE TWO PASSES WITH THE ACE60 AND GUIDE CATHETER AND A THROMBOLYSIS IN CEREBRAL INFARCTION (TICI) SCORE OF 2A WAS ACHIEVED. NO PROCEDURAL COMPLICATIONS NOR DEVICE DEFICIENCIES WERE REPORTED TO HAVE OCCURRED DURING THE PROCEDURE. HOWEVER, A CONTRAST RUN REVEALED SLIGHT INTRACRANIAL HEMORRHAGE. THE RELATIONSHIP BETWEEN THE ACE60 AND THE INTRACRANIAL HEMORRHAGE IS UNKNOWN. IT WAS REPORTED THAT NO ADDITIONAL ACTION WAS TAKEN TO TREAT THE HEMORRHAGE; HOWEVER, THE PATIENT WAS IN STABLE CONDITION AND WAS TRANSFERRED TO ANOTHER HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    664377 PENUMBRA SYSTEM ACE 60 REPERFUSION CATHETER NRY NRY PENUMBRA, INC. 5MAXACE132KIT-A F90442 00814548017433

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR