BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM FLASH ASPIRATION CATHETER

    MDR report key: 20141482 · Received September 4, 2024

    Report

    Report Number
    3005168196-2024-00302
    Event Type
    Injury
    Date Received
    September 4, 2024
    Date of Event
    July 30, 2024
    Report Date
    November 7, 2024
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948029453
    PMA / PMN Number
    K240030
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE DEVICE ASSOCIATED WITH THIS COMPLAINT WAS EXPECTED TO BE RETURNED; HOWEVER, THE DEVICE IS NOT AVAILABLE FOR RETURN. 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, NON CONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. H3 OTHER TEXT : PLACEHOLDER.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER. DURING THE PROCEDURE, POST FIRST CLOT REMOVAL THE PATIENT EXPERIENCED SUPRA VENTRICULAR TACHYCARDIA (SVT). THEN THE HEART RATE (HR) DECREASED (BRADYCARDIA) FROM 152 TO 66 BEATS PER MINUTE (BPM), SYSTOLIC BLOOD PRESSURE (BP) DECREASED FROM 134 MMHG TO 109 MMHG WHICH WAS LIKELY A VAGAL EPISODE. THE EVENT RESOLVED WITH HR AT 109 BPM. ATROPINE WAS ADMINISTERED AND THROMBUS REMOVAL WAS CONTINUED. SVT WAS UNRELATED TO THE INDIGO SYSTEM. BRADYCARDIA WAS REPORTED TO BE AN ADVERSE EVENT WITH A POSSIBLE RELATIONSHIP TO THE INDIGO SYSTEM AND A POSSIBLE RELATIONSHIP TO THE INDEX PROCEDURE. THE EVENT IS CONSIDERED RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    699445 INDIGO SYSTEM FLASH ASPIRATION CATHETER QEW QEW PENUMBRA, INC. F00010054 00815948029453

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Required Intervention