BEUDAMED
    FDA Adverse Event Death Summary report: N

    INDIGO SYSTEM ASPIRATION CATHETER 8

    MDR report key: 18070227 · Received November 4, 2023

    Report

    Report Number
    3005168196-2023-00487
    Event Type
    Death
    Date Received
    November 4, 2023
    Date of Event
    October 5, 2023
    Report Date
    November 16, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    PMA / PMN Number
    K192833
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PLEASE NOTE THAT THE FOLLOWING SECTIONS WERE INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND ARE BEING CORRECTED ON THIS FOLLOW-UP #01 MFR REPORT:3005168196-2023-00487. 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM. 2. SECTION H. BOX 10/11. ADDITIONAL NARRATIVE AND/OR CORRECTED DATA. NARRATIVE/CORRECTED DATA. VESSEL PERFORATION AND DEATH ARE INCLUDED AS POSSIBLE COMPLICATIONS IN THE INSTRUCTIONS FOR USE FOR THE INDIGO ASPIRATION SYSTEM. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 1.3005168196-2023-00486 H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 0

    VESSEL PERFORATION AND DEATH ARE INCLUDED AS POSSIBLE COMPLICATIONS IN THE INSTRUCTIONS FOR USE FOR THE INDIGO ASPIRATION SYSTEM. FROM THE INFORMATION PROVIDED, THERE IS NO INDICATION THAT THERE WAS ANY DEVICE MALFUNCTION, NONCONFORMANCE, OR MISUSE THAT CONTRIBUTED TO THE REPORTED EVENT. THE PRODUCT WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE DEVICE, THE ROOT CAUSE OF THE PROBLEM CANNOT BE DETERMINED. THE PRODUCT LOT NUMBER WAS NOT PROVIDED, THEREFORE, THE MANUFACTURING RECORDS COULD NOT BE REVIEWED. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 1.3005168196-2023-00486.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE RIGHT PULMONARY ARTERY (PA) USING AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING), AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A NON-PENUMBRA PIGTAIL CATHETER, A NON-PENUMBRA SHEATH, AND GUIDEWIRES. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY HAD AN ACUTE TURN INTO THE RIGHT PA. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE PIGTAIL CATHETER OVER THE FIRST GUIDEWIRE TO THE MAIN PA. THE FIRST GUIDEWIRE WAS EXCHANGED FOR ANOTHER GUIDEWIRE AND USED TO DELIVER THE SHEATH TO THE MAIN PA. IT WAS REPORTED THAT THE PATIENT BEGAN TO EXPERIENCE CHEST PAIN WHEN THE SHEATH WAS PLACED IN THE MAIN PA. THE DIAGNOSTIC CATHETER WAS ADVANCED OVER THE GUIDEWIRE THROUGH THE SHEATH TO THE DISTAL RIGHT PA. THE FLASH CATHETER WAS NOT ABLE TO ADVANCE TO THE RIGHT PA WITHOUT SUPPORT, THEREFORE, THE CAT8 WAS USED TO HELP DELIVER THE FLASH CATHETER. THE FLASH CATHETER WAS STILL NOT ABLE TO ADVANCE PAST THE BEND IN THE RIGHT PA. THE PHYSICIAN REMOVED THE CAT8 AND BEGAN ASPIRATION IN THE MAIN PA USING THE FLASH CATHETER. AFTER ASPIRATION, THE PHYSICIAN PERFORMED AN ANGIOGRAM AND IDENTIFIED A PERFORATION NEAR THE MAIN AND LEFT PA. THE PHYSICIAN THEN ATTEMPTED TO TREAT THE PERFORATION WITH A BALLOON TAMPONADE AND SEALED THE PERFORATION USING A NON-PENUMBRA BALLOON DEVICE. THE PROCEDURE ENDED AT THIS POINT. IT WAS REPORTED THAT THE PATIENT EXPIRED POST-PROCEDURE. THE CAUSE OF DEATH IS CARDIAC ARREST. IT IS UNKNOWN IF THE CAUSE OF DEATH WAS RELATED TO THE PENUMBRA DEVICES.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN LEFT MAIN PULMONARY ARTERY (PA) USING AN INDIGO SYSTEM LIGHTNING FLASH ASPIRATION TUBING (FLASH TUBING), AN INDIGO SYSTEM FLASH ASPIRATION CATHETER (FLASH CATHETER), AN INDIGO SYSTEM ASPIRATION CATHETER 8 (CAT8), A NON-PENUMBRA PIGTAIL CATHETER, A NON-PENUMBRA SHEATH, AND GUIDEWIRES. IT WAS REPORTED THAT THE PATIENT¿S ANATOMY HAD AN ACUTE TURN INTO THE RIGHT PA. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE PIGTAIL CATHETER OVER THE FIRST GUIDEWIRE TO THE MAIN PA. THE FIRST GUIDEWIRE WAS EXCHANGED FOR ANOTHER GUIDEWIRE AND USED TO DELIVER THE SHEATH TO THE MAIN PA. IT WAS REPORTED THAT THE PATIENT BEGAN TO EXPERIENCE CHEST PAIN WHEN THE SHEATH WAS PLACED IN THE MAIN PA. THE DIAGNOSTIC CATHETER WAS ADVANCED OVER THE GUIDEWIRE THROUGH THE SHEATH TO THE DISTAL RIGHT PA. THE FLASH CATHETER WAS NOT ABLE TO ADVANCE TO THE RIGHT PA WITHOUT SUPPORT, THEREFORE, THE CAT8 WAS USED TO HELP DELIVER THE FLASH CATHETER. THE FLASH CATHETER WAS STILL NOT ABLE TO ADVANCE PAST THE BEND IN THE RIGHT PA. THE PHYSICIAN REMOVED THE CAT8 AND BEGAN ASPIRATION IN THE MAIN PA USING THE FLASH CATHETER. AFTER ASPIRATION, THE PHYSICIAN PERFORMED AN ANGIOGRAM AND IDENTIFIED A PERFORATION NEAR THE MAIN AND LEFT PA. THE PHYSICIAN THEN ATTEMPTED TO TREAT THE PERFORATION WITH A BALLOON TAMPONADE AND SEALED THE PERFORATION USING A NON-PENUMBRA BALLOON DEVICE. THE PROCEDURE ENDED AT THIS POINT. IT WAS REPORTED THAT THE PATIENT EXPIRED POST-PROCEDURE. THE CAUSE OF DEATH IS CARDIAC ARREST. IT IS UNKNOWN IF THE CAUSE OF DEATH WAS RELATED TO THE PENUMBRA DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953119 INDIGO SYSTEM ASPIRATION CATHETER 8 QEW QEW PENUMBRA, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Female Death| R