BEUDAMED
    FDA Adverse Event Death Summary report: N

    INDIGO SYSTEM SEPARATOR 7

    MDR report key: 14367112 · Received May 12, 2022

    Report

    Report Number
    3005168196-2022-00211
    Event Type
    Death
    Date Received
    May 12, 2022
    Date of Event
    April 14, 2022
    Report Date
    July 29, 2022
    Manufacturer
    PENUMBRA, INC.
    Product Code
    QEW
    UDI-DI
    00815948024021
    PMA / PMN Number
    K210083
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS DEVICE IS AVAILABLE FOR RETURN. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE DEVICE INVESTIGATION. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2022-00210.

    Additional Manufacturer Narrative · 0

    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: 3005168196-2022-00211. 1. SECTION B. BOX 5. DESCRIBE EVENT OR PROBLEM. PLEASE NOTE THAT THE FOLLOWING SECTION WAS INADVERTENTLY MISSED ON THE INITIAL MFR REPORT AND IS BEING INCLUDED ON THIS FOLLOW-UP #01 MFR REPORT: 3005168196-2022-00211. 1. SECTION H. BOX 6. PATIENT CODE 3. EVALUATION OF THE RETURNED CAT7 REVEALED A FUNCTIONAL DEVICE. FURTHER EVALUATION OF THE DEVICE REVEALED SOME BENDS ALONG THE LENGTH OF THE DEVICE. THIS LIKELY OCCURRED DURING PACKAGING FOR THE DEVICE RETURN AND WAS INCIDENTAL TO THE REPORTED EVENT. THERE WAS NO REPORT OF A CAT7 DEVICE MALFUNCTION IN THE REPORTED EVENT. EVALUATION OF THE RETURNED SEP7 REVEALED AN UNDAMAGED AND FUNCTIONAL DEVICE. THE SEP7 WAS ABLE TO ADVANCE THROUGH THE RETURNED CAT7 WITHOUT AN ISSUE. THERE WAS NO REPORT OF A SEP7 DEVICE MALFUNCTION IN THE REPORTED EVENT. VESSEL PERFORATION, HEMOPTYSIS, AND RESPIRATORY FAILURE ARE INCLUDED AS POSSIBLE COMPLICATIONS IN THE INSTRUCTIONS FOR USE (IFU) FOR THE INDIGO ASPIRATION SYSTEM. PENUMBRA CATHETERS AND SEPARATORS ARE 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. THIS REPORT IS ASSOCIATED WITH MFR REPORT NUMBER: 3005168196-2022-00210.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT PULMONARY ARTERY USING AN INDIGO SYSTEM CAT7 ASPIRATION CATHETER (CAT7), AN INDIGO SYSTEM SEPARATOR 7 (SEP7), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S PULMONARY EMBOLISM HAD BEEN TREATED WITH AN EKOS SYSTEM TO REDUCE/DISSOLVE THE CLOT BURDEN IN THE PULMONARY VASCULATURE. IN ADDITION, WITH THE EKOS SYSTEM, THE PATIENT WAS ALSO GIVEN LYSIS UNTIL THE DAY BEFORE THE PROCEDURE. HOWEVER, A SUBSEQUENT CTA SCAN INDICATED THERE WAS CLOT REMAINING IN THE LEFT PULMONARY ARTERY. THEREFORE, THE PHYSICIAN MADE THE DECISION TO PERFORM A THROMBECTOMY PROCEDURE TO REMOVE/REDUCE THE REMAINING CLOT BURDEN. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SHEATH OVER A GUIDEWIRE INTO THE PULMONARY ARTERY TRUNK VIA A PUNCTURE OVER THE FEMORAL VEIN. THE PHYSICIAN THEN ADVANCED THE CAT7 AND SEP7 THROUGH THE SHEATH AND THEN PLACED THE SHEATH IN THE LEFT PULMONARY ARTERY. THE CAT7 AND SEP7 WERE THEN ADVANCED INTO THE LOWER LOBE VASCULATURE. THE PHYSICIAN THEN INITIATED ASPIRATION AND WORKED FOR APPROXIMATELY THIRTY MINUTES UNDER ASPIRATION TO REMOVE THE CLOT. IT WAS REPORTED THAT THE CAT7 WAS NEVER REMOVED TO FLUSH SINCE THE CAT7 WAS NEVER CLOGGED FOR MORE THAN 40 SECONDS. IT WAS ALSO REPORTED THAT WITH THE CORRECT USE OF THE SEP7 OF HAVING APPROXIMATELY, 1.5-2 CENTIMETERS STICKING OUT OF THE DISTAL END OF THE CAT7 THROUGHOUT THE PROCEDURE, THE PHYSICIAN WAS THEN ABLE TO BRING BACK FLOW ON THE CAT7 FOR THE ENTIRE PROCEDURE. AFTERWARDS, THE PHYSICIAN STOPPED THE FLOW FROM THE CAT7 BY TURNING OFF THE FLOW SWITCH TO PERFORM AN ANGIOGRAPHY TO SEE HOW MUCH CLOT WAS LEFT. SUBSEQUENTLY, THE PATIENT STARTED COUGHING BLOOD AND THEN IT COULD BE SEEN ON THE MONITOR THAT THE OXYGEN SATURATION WAS DECREASING. AN EMERGENCY TEAM WAS THEN CALLED, AND THE PATIENT HAD TO BE RESUSCITATED. AFTER APPROXIMATELY, 40-60 MINUTES IT WAS DETERMINED THAT THE PATIENT COULD NOT RE-ESTABLISH HEART FUNCTION. IT WAS REPORTED THAT THE HEMOPTYSIS WAS DUE TO A PERFORATION OF THE PULMONARY VASCULATURE. THE RELATIONSHIP BETWEEN THE HEMOPTYSIS TO THE CAT7 IS UNKNOWN. THE CAUSE OF DEATH WAS REPORTED TO BE A RESPIRATORY INSUFFICIENCY DUE TO PERFORATION OF THE PULMONARY VASCULATURE THAT RESULTED IN A CIRCULATORY COLLAPSE.

    Description of Event or Problem · 0

    THE PATIENT WAS UNDERGOING A THROMBECTOMY PROCEDURE IN THE LEFT PULMONARY ARTERY USING AN INDIGO SYSTEM CAT7 ASPIRATION CATHETER (CAT7), AN INDIGO SYSTEM SEPARATOR 7 (SEP7), A NON-PENUMBRA SHEATH AND A GUIDEWIRE. IT WAS NOTED THAT THE PATIENT¿S PULMONARY EMBOLISM HAD BEEN TREATED WITH AN EKOS SYSTEM TO REDUCE/DISSOLVE THE CLOT BURDEN IN THE PULMONARY VASCULATURE. IN ADDITION, WITH THE EKOS SYSTEM, THE PATIENT WAS ALSO GIVEN LYSIS UNTIL THE DAY BEFORE THE PROCEDURE. HOWEVER, A SUBSEQUENT CTA SCAN INDICATED THERE WAS CLOT REMAINING IN THE LEFT PULMONARY ARTERY. THEREFORE, THE PHYSICIAN MADE THE DECISION TO PERFORM A THROMBECTOMY PROCEDURE TO REMOVE/REDUCE THE REMAINING CLOT BURDEN. DURING THE PROCEDURE, THE PHYSICIAN ADVANCED THE SHEATH OVER A GUIDEWIRE INTO THE PULMONARY ARTERY TRUNK VIA A PUNCTURE OVER THE FEMORAL VEIN. THE PHYSICIAN THEN ADVANCED THE CAT7 AND SEP7 THROUGH THE SHEATH AND THEN PLACED THE SHEATH IN THE LEFT PULMONARY ARTERY. THE CAT7 AND SEP7 WERE THEN ADVANCED INTO THE LOWER LOBE VASCULATURE. THE PHYSICIAN THEN INITIATED ASPIRATION AND WORKED FOR APPROXIMATELY THIRTY MINUTES UNDER ASPIRATION TO REMOVE THE CLOT. IT WAS REPORTED THAT THE CAT7 WAS NEVER REMOVED TO FLUSH SINCE THE CAT7 WAS NEVER CLOGGED FOR MORE THAN 40 SECONDS. IT WAS ALSO REPORTED THAT WITH THE CORRECT USE OF THE SEP7 OF HAVING APPROXIMATELY, 1.5-2 CENTIMETERS STICKING OUT OF THE DISTAL END OF THE CAT7 THROUGHOUT THE PROCEDURE, THE PHYSICIAN WAS THEN ABLE TO BRING BACK FLOW ON THE CAT7 FOR THE ENTIRE PROCEDURE. AFTERWARDS, THE PHYSICIAN STOPPED THE FLOW FROM THE CAT7 BY TURNING OFF THE FLOW SWITCH TO PERFORM AN ANGIOGRAPHY TO SEE HOW MUCH CLOT WAS LEFT. SUBSEQUENTLY, THE PATIENT STARTED COUGHING BLOOD AND THEN IT COULD BE SEEN ON THE MONITOR THAT THE OXYGEN SATURATION WAS DECREASING. AN EMERGENCY TEAM WAS THEN CALLED, AND THE PATIENT HAD TO BE RESUSCITATED. AFTER APPROXIMATELY, 40-60 MINUTES IT WAS DETERMINED THAT THE PATIENT COULD NOT RE-ESTABLISH HEART FUNCTION. IT WAS REPORTED THAT THE HEMOPTYSIS WAS DUE TO A PERFORATION OF THE PULMONARY VASCULATURE. THE RELATIONSHIP BETWEEN THE HEMOPTYSIS, THE CAT7 AND SEP7 IS UNKNOWN. THE CAUSE OF DEATH WAS REPORTED TO BE A RESPIRATORY INSUFFICIENCY DUE TO PERFORATION OF THE PULMONARY VASCULATURE THAT RESULTED IN A CIRCULATORY COLLAPSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2130978 INDIGO SYSTEM SEPARATOR 7 QEW QEW PENUMBRA, INC. C33127 00815948024021

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Death