BEUDAMED
    FDA Adverse Event Death Summary report: N

    INDIGO SYSTEM FLASH ASPIRATION CATHETER

    MDR report key: 17056871 · Received June 5, 2023

    Report

    Report Number
    3005168196-2023-00262
    Event Type
    Death
    Date Received
    June 5, 2023
    Date of Event
    May 9, 2023
    Report Date
    July 6, 2023
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948024885
    PMA / PMN Number
    K222358
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: PLEASE NOTE THAT THE FOLLOWING SECTION WAS INCORRECTLY REPORTED ON THE INITIAL MFR REPORT AND IS BEING CORRECTED ON THIS FOLLOW-UP 01 MFR REPORT:3005168196-2023-00262 1. SECTION H. BOX 3. DEVICE RETURNED TO MANUFACTURER? ADDITIONAL INFO: 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 A POSSIBLE COMPLICATION IN THE INSTRUCTIONS FOR USE (IFU) FOR THE INDIGO ASPIRATION SYSTEM. EVALUATION OF THE RETURNED FLASH CATHETER REVEALED THAT THE CATHETER WAS FUNCTIONAL. DURING EVALUATION, THE FLASH CATHETER WAS CONNECTED TO BOTH RETURNED LIGHTNING UNITS AND FUNCTIONED AS INTENDED. FURTHER EVALUATION REVEALED KINK IN THE CATHETER SHAFT. THIS DAMAGE WAS INCIDENTAL TO THE REPORTED COMPLAINT AND LIKELY OCCURRED DURING PACKAGING OF THE DEVICE FOR RETURN. THERE WAS NO REPORTED ISSUE ON THE RETURNED FLASH CATHETER. PENUMBRA CATHETERS ARE VISUALLY INSPECTED DURING IN-PROCESS INSPECTION AND DURING QUALITY INSPECTION AFTER MANUFACTURING. THE MANUFACTURING RECORDS FOR THIS LOT WERE REVIEWED AND DID NOT REVEAL ANY OUTSTANDING DISCREPANCIES, DESIGN, OR QUALITY CONCERNS. H3 OTHER TEXT : PLACEHOLDER.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RETURNED AND THE INVESTIGATION RESULTS ARE PENDING. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION.

    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) AND A NON-PENUMBRA GUIDE SHEATH. IT SHOULD BE NOTED THAT THE PATIENT HAD AN ECHOCARDIOGRAM (ECHO) STUDY, AND AN ATRIAL SEPTAL DEFECT WAS FOUND ON THE ECHO. IT WAS ALSO REPORTED THAT THE PATIENT WAS OBESE AND WAS COMPLAINING OF TIGHTNESS IN CHEST. THE PATIENT WAS ALSO EXPERIENCING HEAVY SWEATING AND HAD A MULTITUDE OF COLD COMPRESSES PLACED. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO ACCESS THE TARGET VESSEL USING THE GUIDE SHEATH; HOWEVER, HE HAD DIFFICULTY GAINING ACCESS. AFTER OVER AN HOUR, ACCESS WAS GAINED TO THE LEFT PULMONARY ARTERY AND THE FLASH CATHETER WAS ADVANCED INTO THE CLOT; HOWEVER, THE FLASH TUBING IMMEDIATELY WENT INTO A FLASHING YELLOW MODE WITHOUT A CLICKING SOUND. IT WAS REPORTED THAT THE FLASH CATHETER WAS NOT ASPIRATING BLOOD. THEREFORE, THE FLASH CATHETER WAS REMOVED, AND NO CLOT WAS NOTICED TO BE PRESENT IN THE FLASH CATHETER. THE PHYSICIAN RE-ADVANCED THE FLASH CATHETER INTO THE TARGET LOCATION; HOWEVER, THE SAME ISSUE OCCURRED. THE FLASH CATHETER WAS PULLED BACK INTO THE SHEATH AND SOME BLOOD WAS NOTICED TO BE MOVING THROUGH THE CATHETER BUT THERE WAS NO CLOT. THEREFORE, THE FLASH CATHETER WAS REMOVED, AND SALINE WAS FLUSHED THROUGH THE CATHETER. NEXT, THE PHYSICIAN AGAIN ADVANCED THE FLASH CATHETER INTO THE TARGET LOCATION; HOWEVER, THE FLASH TUBING AGAIN TURNED TO FLASHING YELLOW WITHOUT A CLICKING SOUND. THE FLASH CATHETER WAS REMOVED AGAIN AND THERE WAS NO CLOT FOUND IN THE CATHETER. AT THIS POINT, THE FLASH TUBING WAS REMOVED, AND A NEW FLASH TUBING WAS PLACED ON TOP OF THE CANISTER. THE PHYSICIAN THEN ADVANCED THE SAME FLASH CATHETER TO THE TARGET LOCATION. INITIALLY THE FLASH TUBING WENT INTO YELLOW MODE WITHOUT CLICKING AND THEN WENT INTO CLICKING BUT WITHOUT A SIGNIFICANT FLOW. THE FLASH CATHETER WAS PULLED BACK INTO THE SHEATH AND WAS RE-ADVANCED. AT THIS POINT, THE FLASH TUBING WAS CLICKING IN YELLOW MODE. THE FLASH CATHETER WAS REMOVED FROM THE PATIENT'S BODY WITH A POSSIBILITY THAT CLOT WAS REMOVED. THE PHYSICIAN THEN STARTED TO GET READY TO TAKE A DIGITAL SUBTRACTION ANGIOGRAPHY (DSA) RUN THROUGH THE GUIDE SHEATH. HOWEVER, THE PATIENT STARTED TO CODE ON THE TABLE. A STROKE CODE AND A BLUE CODE WAS CALLED. THE PATIENT TEMPORARILY CAME BACK; HOWEVER, CODED AGAIN. CPR WAS ENGAGED FOR ONE HOUR AND ATTEMPTS WERE MADE TO RECOVER THE PATIENT. THE PATIENT WAS DECLARED DECEASED DUE TO CARDIAC TAMPONADE AS PATIENT HAD BLOOD IN THE PERICARDIUM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33062 INDIGO SYSTEM FLASH ASPIRATION CATHETER QEW QEW PENUMBRA, INC. F00004645 00815948024885

    Patients

    Seq Age Sex Outcome Treatment
    1 25 YR Male Death