BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER

    MDR report key: 17476645 · Received August 7, 2023

    Report

    Report Number
    3005168196-2023-00380
    Event Type
    Injury
    Date Received
    August 7, 2023
    Date of Event
    September 1, 2019
    Report Date
    August 7, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    PMA / PMN Number
    K192833
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL 510(K)#S THAT ALSO APPLY TO THIS COMPLAINT: K142870, K160533, K161523. 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. DISTAL EMBOLIZATION 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

    DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES ON 12-JUL-2023, PENUMBRA INC. BECAME AWARE OF A JOURNAL ARTICLE TITLED, "PENUMBRA INDIGO PERCUTANEOUS ASPIRATION THROMBECTOMY SYSTEM IN THE TREATMENT OF AORTIC ENDOGRAFT ILIAC LIMB OCCLUSION: RESULTS FROM AN ITALIAN MULTICENTRE REGISTRY" (SPATH P. ET AL. 2023). IN THIS RETROSPECTIVE, OBSERVATIONAL, MULTICENTER STUDY, SEVENTEEN PATIENTS UNDERWENT ASPIRATION THROMBECTOMY FOR ILIAC LIMB OCCLUSION (ILO) AFTER ENDOVASCULAR AORTIC REPAIR (EVAR) USING INDIGO SYSTEM CAT8 ASPIRATION CATHETER (CAT8) OR INDIGO SYSTEM CATD ASPIRATION CATHETER (CATD) WITH OR WITHOUT AN INDIGO SYSTEM SEPARATOR 8 (SEP8) OR INDIGO SYSTEM SEPARATOR D (SEPD) BETWEEN SEPTEMBER 2019 AND DECEMBER 2021. ONE PATIENT WHO UNDERWENT ASPIRATION THROMBECTOMY FOR ILO USING THE INDIGO SYSTEM REQUIRED MULTIPLE PASSES TO ACHIEVE THE THROMBUS REMOVAL. IT WAS REPORTED THAT THE PATIENT HAD INTRA-OPERATIVE DISTAL EMBOLIZATION, WHICH WAS EFFECTIVELY TREATED WITH THROMBO-ASPIRATION IN THE SAME SESSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741050 INDIGO SYSTEM ASPIRATION CATHETER QEW QEW PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention