BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER

    MDR report key: 22902965 · Received August 27, 2025

    Report

    Report Number
    3005168196-2025-00275
    Event Type
    Injury
    Date Received
    August 27, 2025
    Date of Event
    August 1, 2023
    Report Date
    August 27, 2025
    Manufacturer
    PENUMBRA, INC.
    Product Code
    NRY
    PMA / PMN Number
    K222808
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THEREFORE, A PHYSICAL DEVICE INVESTIGATION WAS UNABLE TO BE PERFORMED. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. PENUMBRA WAS UNABLE TO OBTAIN ENOUGH DEVICE INFORMATION TO IDENTIFY THE CATALOG AND LOT NUMBER. THE ONLY DEVICE IDENTIFIERS KNOWN ARE: D1 (BRAND NAME), D2A (COMMON DEVICE NAME), AND D2B (PRODUCT CODE). WITHOUT THE CATALOG NUMBER FOR THIS DEVICE, UNIQUE DEVICE IDENTIFIER (UDI) CANNOT BE DETERMINED.

    Description of Event or Problem · 0

    ON 4-AUG-2025, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "A SINGLE-CENTER STUDY OF THE RED 72 REPERFUSION CATHETER WITH SENDIT TECHNOLOGY IN PROXIMAL LARGE VESSEL OCCLUSIONS" (DHAR ET AL. 2025). IN THIS SINGLE-CENTER RETROSPECTIVE STUDY, THIRTY-SEVEN PATIENTS WITH PROXIMAL LARGE VESSEL OCCLUSIONS AFFECTING THE INTERNAL CAROTID ARTERY, M1, OR M2 UNDERWENT THROMBECTOMY PROCEDURES BETWEEN AUGUST 2023 AND MAY 2024. IN ALL CASES, A PENUMBRA SYSTEM RED 72 REPERFUSION CATHETER (RED72) AND A SENDIT DELIVERY DEVICE (SENDIT) WERE USED TOGETHER WITH A NON-PENUMBRA MICROWIRE AND OTHER DEVICES. IT WAS REPORTED THAT INTRACRANIAL HEMORRHAGE (ICH) WAS OBSERVED IN A TOTAL OF FOURTEEN CASES, INCLUDING TWO CASE OF SYMPTOMATIC ICH (SICH). IN ONE CASE WITH A TANDEM OCCLUSION OF THE ICA AND M1, THE SENDIT WAS USED ON THE FIRST PASS AFTER ANGIOPLASTY; HOWEVER, IT PUSHED THE THROMBUS TO THE MID-M1 SEGMENT. A SECOND PASS WITH A STENTRIEVER (UNKNOWN) WAS REQUIRED TO ACHIEVE RECANALIZATION. IN ANOTHER CASE, AFTER UNSUCCESSFUL RECANALIZATION OF AN M2 OCCLUSION USING THE RED72 AND THE SENDIT, AN ATTEMPT WAS MADE WITH A PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER (RED43), WHICH RESULTED IN AN M1 OCCLUSION. RECANALIZATION OF THE M1 WAS ACHIEVED WITH A SECOND ATTEMPT USING THE RED 72 AND SENDIT. HOWEVER, THIS LED TO VASOSPASM, AND FAILED TO CLEAR THE INITIAL M2 OCCLUSION, WHICH ULTIMATELY REQUIRED RECANALIZATION WITH A STENTRIEVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1498128 PENUMBRA SYSTEM RED 43 REPERFUSION CATHETER NRY NRY PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention