BEUDAMED
    FDA Adverse Event Death Summary report: N

    INDIGO SYSTEM SEPARATOR 12

    MDR report key: 13031216 · Received December 17, 2021

    Report

    Report Number
    3005168196-2021-02787
    Event Type
    Death
    Date Received
    December 17, 2021
    Date of Event
    November 16, 2021
    Report Date
    December 17, 2021
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948021556
    PMA / PMN Number
    K202821
    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. POTENTIAL ADVERSE EVENTS IN THE LABELING WITH THE INDIGO ASPIRATION SYSTEM INCLUDE, BUT ARE NOT LIMITED TO, VESSEL SPASM, THROMBOSIS, DISSECTION OR PERFORATION, HEMATOMA OR HEMORRHAGE AT ACCESS SITE, INCLUDING DEATH. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 1.3005168196-2021-02786 .

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE PULMONARY ARTERY USING AN INDIGO SYSTEM ASPIRATION CATHETER 12 (CAT12), LIGHTNING ASPIRATION TUBING (LIGHTNING), INDIGO SYSTEM SEPARATOR 12 (SEP12), AND NON-PENUMBRA CATHETER. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED A NON-PENUMBRA CATHETER INTO THE PULMONARY ARTERY AND INJECTED FOUR MILLIGRAMS OF TISSUE PLASMINOGEN ACTIVATOR (TPA) IN BOTH THE RIGHT AND LEFT LUNG. NEXT, THE CAT12 WAS INSERTED INTO THE MAIN PULMONARY ARTERY ON THE LEFT SIDE TO BEGIN ASPIRATING THE THROMBUS. IT WAS REPORTED THAT THE PHYSICIAN DID NOT FEEL ANY RESISTANCE DURING ADVANCEMENT OF THE CAT12 INTO THE PULMONARY ARTERY OR WHILE ASPIRATING IN THE LEFT MAIN MEDIAL PART OF THE PULMONARY ARTERY USING THE CAT12 AND SEP12. AFTER A COUPLE OF MINUTES OF ASPIRATION, THE PATIENT BEGAN TO EXPERIENCE HEMOPTYSIS AND, THEREFORE, THE PHYSICIAN STOPPED ASPIRATION AND THE PATIENT STABILIZED. SUBSEQUENTLY, THE PHYSICIAN PERFORMED A HAND INJECTED ANGIOGRAPHY THAT DID NOT REVEAL ANY SIGNS OF TRAUMA; HOWEVER, THE PHYSICIAN DID NOTICE INFILTRATION IN THE LUNGS. IT WAS ALSO REPORTED THE CAUSE OF THE INFILTRATION OF THE LUNGS WAS UNKNOWN. THE PHYSICIAN DECIDED TO END THE PROCEDURE AT THIS POINT AND THE PATIENT WAS TRANSPORTED INTO AN INTENSIVE CARE UNIT (ICU) TO RECOVER. WHILE IN THE ICU, THE PATIENT STARTED TO DESATURATE, SUBSEQUENTLY, UPON ATTEMPTING TO INTUBATE THE PATIENT, THE PATIENT BEGAN TO EXPERIENCE MORE HEMOPTYSIS. APPROXIMATELY AN HOUR LATER, THE PATIENT EXPIRED. THE RELATIONSHIP BETWEEN THE CAT12 AND SEP12 TO PATIENT'S DEATH IS UNKNOWN. THE CAUSE OF THE PATIENT¿S DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922422 INDIGO SYSTEM SEPARATOR 12 QEW QEW PENUMBRA, INC. SEP12-A F105578 00815948021556

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Death