BEUDAMED
    FDA Adverse Event Death Summary report: N

    INDIGO SYSTEM FLASH ASPIRATION CATHETER

    MDR report key: 17628463 · Received August 25, 2023

    Report

    Report Number
    3005168196-2023-00405
    Event Type
    Death
    Date Received
    August 25, 2023
    Date of Event
    July 26, 2023
    Report Date
    August 25, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    PMA / PMN Number
    K222358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 DEATH IS INCLUDED AS 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. PLACEHOLDER.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERIES USING AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING), AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), A SELECT CATHETER, AND A GUIDEWIRE. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE FLASH CATHETER OVER THE SELECT CATHETER TO THE LEFT PULMONARY ARTERY AND INITIATED ASPIRATION. IT WAS REPORTED THAT THE PHYSICIAN WAS SUCCESSFUL ASPIRATING CLOT. AFTER ASPIRATING, AN ANGIOGRAM WAS PERFORMED, AND SOME THROMBUS WAS STILL NOTICED. THE PHYSICIAN CONTINUED WITH THE PROCEDURE AND SUBSEQUENTLY, NOTICED THAT THE PATIENT DEVELOPED A COUGH, AND THE OXYGEN LEVEL WAS SLOWLY DECLINING. IT WAS REPORTED THE PATIENT WAS GIVEN AN INCREASE OF SUPPLEMENTAL OXYGEN. THE PATIENT DEVELOPED A WET COUGH AND CONTINUED TO DECLINE IN OXYGEN SATURATION. ORAL SUCTIONING WAS PERFORMED, AND HEMOPTYSIS WAS NOTICED. THE PHYSICIAN REMOVED THE CATHETERS AND SHEATHS FROM THE PATIENT AND THE CODE TEAM WAS CALLED. THE PATIENT THEN LEFT THE INTERVENTIONAL RADIOLOGY (IR) ROOM STABLE; HOWEVER, WAS VENTILATED AND WAS TAKEN TO ICU. THE PATIENT EXPIRED SHORTLY AFTER. THE PHYSICIAN REPORTED THAT THE CAUSE OF HEMOPTYSIS IS UNKNOWN AND INDICATED THAT THE FLASH CATHETER IS NOT RELATED TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    889408 INDIGO SYSTEM FLASH ASPIRATION CATHETER QEW QEW PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death