BEUDAMED
    FDA Adverse Event Death Summary report: N

    INDIGO SYSTEM FLASH ASPIRATION CATHETER

    MDR report key: 19793694 · Received July 22, 2024

    Report

    Report Number
    3005168196-2024-00254
    Event Type
    Death
    Date Received
    July 22, 2024
    Date of Event
    June 22, 2024
    Report Date
    July 19, 2024
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    PMA / PMN Number
    K222358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, 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. AFTER MULTIPLE ATTEMPTS, THE PENUMBRA SALES REPRESENTATIVE WAS UNABLE TO OBTAIN ENOUGH DEVICE INFORMATION TO IDENTIFY THE CATALOG NUMBER. THE ONLY DEVICE IDENTIFIERS KNOWN ARE: D1(BRAND NAME), D2A (COMMON DEVICE NAME), AND D2B (PRODUCT CODE). WITHOUT THE CATALOG NUMBER FOR THIS DEVICE, UNIQUE DEVICE IDENTIFIER (UDI) CANNOT BE DETERMINED. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT AND RIGHT PULMONARY ARTERIES USING AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), A NON-PENUMBRA CATHETER (ANGLED PIGTAIL), A BALLOON CATHETER, A GUIDEWIRE, AND A NON-PENUMBRA SHEATH VIA THE RIGHT GROIN. DURING THE PROCEDURE, THE PHYSICIAN PLACED THE SHEATH DISTAL TO THE RIGHT ATRIUM AND ADVANCED THE PIGTAIL CATHETER WITHOUT A GUIDEWIRE INTO THE MAIN PULMONARY ARTERY WHERE PRESSURES AND ANGIOGRAMS WERE TAKEN. LARGE BILATERAL PULMONARY THROMBUS WAS SEEN ON THE ANGIOGRAMS. THE FLASH CATHETER WAS ADVANCED OVER A GUIDEWIRE INTO THE LEFT PULMONARY ARTERY AND AFTER REMOVING THE GUIDEWIRE, ONE PASS WAS SUCCESSFULLY COMPLETED WITH THE FLASH CATHETER. WHEN WITHDRAWING THE FLASH CATHETER INTO THE MAIN LEFT PULMONARY ARTERY, THE PATIENT EXPERIENCED HEMOPTYSIS. THE PATIENT WAS TURNED ON THE LEFT SIDE TO OXYGENATE HER RIGHT LUNG AS THE PHYSICIAN LOOKED FOR A PERFORATION UNDER FLUOROSCOPY; HOWEVER, THE PHYSICIAN WAS NOT ABLE TO LOCATE THE BLEEDING SITE. AS THE PATIENT¿S VITALS BEGAN TO NORMALIZE, THE PATIENT WAS PLACED ON A SUPINE POSITION. THE PHYSICIAN ATTEMPTED TO VISUALIZE A PERFORATION AGAIN UNDER FLUOROSCOPY BUT WAS UNSUCCESSFUL. AS A PRECAUTION MEASURE, THE PHYSICIAN PLACED A BALLOON CATHETER IN THE DISTAL LEFT PULMONARY ARTERY TO SEE IF IT WOULD HELP CONTROL THE BLEEDING, HOWEVER, IT WAS UNSUCCESSFUL. MULTIPLE ROUNDS OF CARDIOPULMONARY RESUSCITATION (CPR) WERE PERFORMED. THE PATIENT EXPIRED AND THE CAUSE OF DEATH WAS RULED AS A PERFORATION. IT IS UNKNOWN IF THE USE OF THE FLASH CATHETER CONTRIBUTED TO THE BLEEDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737569 INDIGO SYSTEM FLASH ASPIRATION CATHETER QEW QEW PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Death| R