BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING

    MDR report key: 19645093 · Received July 1, 2024

    Report

    Report Number
    3005168196-2024-00236
    Event Type
    Injury
    Date Received
    July 1, 2024
    Date of Event
    February 2, 2024
    Report Date
    July 1, 2024
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    PMA / PMN Number
    K222358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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. ANEMIA IS INCLUDED AS A POSSIBLE COMPLICATION IN THE INSTRUCTIONS FOR USE (IFU) FOR THE INDIGO ASPIRATION SYSTEM. THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 0

    ON (B)(6) 2024, THE PATIENT UNDERWENT A THROMBECTOMY PROCEDURE IN THE ILIAC/FEMORAL/POPLITEAL VEINS USING A INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER) AND AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING). ON (B)(6) 2024, THE PATIENT UNDERWENT A VENOGRAM, WHICH SHOWED RE-THROMBOSIS OF THE FEMORAL AND POPLITEAL VEINS. THE ILIAC VEIN WAS PATENT. THE PATIENT WAS ASYMPTOMATIC AND DID NOT REQUIRE FURTHER TREATMENT. RE-THROMBOSIS OF THE TARGET VENOUS SEGMENT WAS REPORTED TO BE A NON-SERIOUS EVENT WITH A POSSIBLE RELATIONSHIP TO THE INDIGO ASPIRATION SYSTEM AND A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE. ON 05-JUN-2024, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT DEVELOPED HYPOTENSION THAT EVENING ON THE DAY OF THE PROCEDURE ((B)(6) 2024). IT WAS NOTED THAT THE PATIENT¿S HEMOGLOBIN DROPPED TO 7.0G/DL FROM A BASELINE OF 9.1G/DL. THE PATIENT WAS ADMINISTERED 1 UNIT OF PACKED RED BLOOD CELLS (PRBC). POST-TRANSFUSION THE HEMOGLOBIN INCREASED TO 9.8G/DL. HEMORRHAGE WAS REPORTED TO BE A SERIOUS ADVERSE EVENT WITH A PROBABLE RELATIONSHIP TO THE INDIGO ASPIRATION SYSTEM AND A PROBABLE RELATIONSHIP TO THE INDEX PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255539 INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING QEW QEW PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention