BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER

    MDR report key: 10393238 · Received August 11, 2020

    Report

    Report Number
    3005168196-2020-01168
    Event Type
    Injury
    Date Received
    August 11, 2020
    Date of Event
    January 1, 2017
    Report Date
    July 15, 2020
    Manufacturer
    PENUMBRA, INC.
    Product Code
    DXE
    PMA / PMN Number
    K160533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL 510(K) #¿S THAT COULD ALSO APPLY TO THIS COMPLAINT: K161523 AND K163618 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 INDIGO ASPIRATION SYSTEM INCLUDE, BUT ARE NOT LIMITED TO, HEMATOMA OR HEMORRHAGE AT ACCESS SITE, INABILITY TO COMPLETELY REMOVE THROMBUS, HEMORRHAGE, VESSEL SPASM, THROMBOSIS, DISSECTION, OR PERFORATION, PERIPHERAL THROMBOEMBOLIC EVENTS. THEREFORE, IT WAS DETERMINED THAT THE REPORTED ADVERSE EVENTS WERE ANTICIPATED COMPLICATIONS. THE PRODUCT LOT NUMBER WAS NOT PROVIDED; THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 1

    PENUMBRA INC. BECAME AWARE ON 15-JUL-2020 DURING ITS POST-MARKET SURVEILLANCE ACTIVITIES OF A JOURNAL ARTICLE TITLED, "ASPIRATION THROMBECTOMY FOR THE MANAGEMENT OF ACUTE DEEP VENOUS THROMBOSIS IN THE SETTING OF VENOUS THORACIC OUTLET SYNDROME." (TETER ET AL., 2020). IT WAS REPORTED THAT 16 PATIENTS WERE TREATED WITH INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8) OR INDIGO SYSTEM CATRX ASPIRATION CATHETER (CATRX) WITH OPTIONAL USE OF INDIGO SYSTEM SEPARATOR 8 (SEP8). ALL DATA WAS GATHERED FROM A MULTICENTER RETROSPECTIVE REVIEW OF PROCEDURES TAKING PLACE IN 2017. AMONG ALL PATIENTS, ONE PATIENT EXPERIENCED MAJOR BLEEDING. HOWEVER, THERE IS NO ALLEGATION WITHIN THE ARTICLE THAT A MALFUNCTION OF THE INDIGO SYSTEM OCCURRED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE OR PATIENT INFORMATION FROM THE ARTICLE, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. THEREFORE, THIS REPORT ADDRESSES ALL ADVERSE EVENTS WITHIN THIS LITERATURE SOURCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857929 INDIGO SYSTEM ASPIRATION CATHETER DXE DXE PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other