BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DOWNSTREAM SYSTEM

    MDR report key: 21887117 · Received April 22, 2025

    Report

    Report Number
    2030964-2025-00001
    Event Type
    Injury
    Date Received
    April 22, 2025
    Date of Event
    March 24, 2025
    Report Date
    June 10, 2025
    Manufacturer
    THEROX, INC.
    Product Code
    MWG
    PMA / PMN Number
    P170027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5 (DESCRIBE EVENT OR PROBLEM), H11 (PROVIDE NARRATIVE/ DATA) WERE UPDATED. D1 (BRAND NAME), D2A (COMMON DEVICE NAME), D4 (ADDITIONAL DEVICE INFORMATION), H8 (USAGE OF DEVICE) WERE CORRECTED. THE THEROX CONSOLE INVOLVED IN THE REPORTED COMPLAINT WILL NOT BE RETURNED FOR EVALUATION PER THE CUSTOMER. THEREFORE, PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. SUPERSATURATED OXYGEN (SSO2) THERAPY IS AN ADJUNCTIVE CARDIAC CATHETERIZATION LABORATORY INITIATED PROCEDURE TARGETED AT THE LEFT MAIN CORONARY ARTERY (LMCA) OF AN ACUTE MYOCARDIAL INFARCTION (AMI) PATIENT AFTER SUCCESSFUL PERCUTANEOUS INTERVENTION (PCI) WITH STENTING HAS BEEN PERFORMED OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE THEROX DOWNSTREAM SYSTEM IS INDICATED FOR THE PREPARATION AND DELIVERY OF SUPERSATURATED OXYGEN THERAPY (SSO2 THERAPY) TO TARGETED ISCHEMIC REGIONS PERFUSED BY THE PATIENT'S LEFT ANTERIOR DESCENDING CORONARY ARTERY IMMEDIATELY FOLLOWING REVASCULARIZATION BY MEANS OF PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH STENTING THAT HAS BEEN COMPLETED WITHIN 6 HOURS AFTER THE ONSET OF ANTERIOR ACUTE MYOCARDIAL INFARCTION (AMI) SYMPTOMS CAUSED BY A LEFT ANTERIOR DESCENDING ARTERY INFARCT LESION. EVENT WAS SERIOUS AS EVENT REQUIRED ADDITIONAL INTERVENTION. ACCORDING TO AVAILABLE INFORMATION, EVENT OF ST ASSESSED AS POSSIBLE RELATED TO THEROX CONSOLE DUE TO RELEVANT TIME AND LOCATION. SEEMS THAT GOAL ACT WAS NOT COMPLETELY ACHIEVED, WHICH COULD POTENTIALLY CONTRIBUTE TO DEVELOPMENT OF ST. THE CUSTOMER PROBABLY WILL BENEFIT FROM ADDITIONAL FOLLOW UP TRAINING. THE EVENT IS POSSIBLY RELATED TO THE DEVICE AND PROCEDURE AND NOT RELATED TO DEVICE DEFICIENCY.

    Additional Manufacturer Narrative · 0

    THE THEROX CATHETER INVOLVED IN THE REPORTED COMPLAINT WILL NOT BE RETURNED FOR EVALUATION PER THE CUSTOMER. THEREFORE, PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED. SUPERSATURATED OXYGEN (SSO2) THERAPY IS AN ADJUNCTIVE CARDIAC CATHETERIZATION LABORATORY INITIATED PROCEDURE TARGETED AT THE LEFT MAIN CORONARY ARTERY (LMCA) OF AN ACUTE MYOCARDIAL INFARCTION (AMI) PATIENT AFTER SUCCESSFUL PERCUTANEOUS INTERVENTION (PCI) WITH STENTING HAS BEEN PERFORMED OF THE LEFT ANTERIOR DESCENDING CORONARY ARTERY. THE THEROX DOWNSTREAM SYSTEM IS INDICATED FOR THE PREPARATION AND DELIVERY OF SUPERSATURATED OXYGEN THERAPY (SSO2 THERAPY) TO TARGETED ISCHEMIC REGIONS PERFUSED BY THE PATIENT'S LEFT ANTERIOR DESCENDING CORONARY ARTERY IMMEDIATELY FOLLOWING REVASCULARIZATION BY MEANS OF PERCUTANEOUS CORONARY INTERVENTION (PCI) WITH STENTING THAT HAS BEEN COMPLETED WITHIN 6 HOURS AFTER THE ONSET OF ANTERIOR ACUTE MYOCARDIAL INFARCTION (AMI) SYMPTOMS CAUSED BY A LEFT ANTERIOR DESCENDING ARTERY INFARCT LESION. EVENT WAS SERIOUS AS EVENT REQUIRED ADDITIONAL INTERVENTION. ACCORDING TO AVAILABLE INFORMATION, EVENT OF ST ASSESSED AS POSSIBLE RELATED TO THEROX DEVICE DUE TO RELEVANT TIME AND LOCATION. SEEMS THAT GOAL ACT WAS NOT COMPLETELY ACHIEVED, WHICH COULD POTENTIALLY CONTRIBUTE TO DEVELOPMENT OF ST. THE CUSTOMER PROBABLY WILL BENEFIT FROM ADDITIONAL FOLLOW UP TRAINING. THE EVENT IS POSSIBLY RELATED TO THE DEVICE AND PROCEDURE AND NOT RELATED TO DEVICE DEFICIENCY.

    Description of Event or Problem · 0

    THE STAFF CALLED THE ZOLL CAS (CLINICAL ACCOUNT SPECIALIST) FOR SET-UP AND INITIATION OF SSO2 THERAPY AFTER PCI (PERCUTANEOUS CORONARY INTERVENTION) TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING THE CALL, THE STAFF INFORMED ZOLL THAT THE ACTIVATED CLOTTING TIME (ACT) WAS 269 AFTER (B)(4) UNITS OF HEPARIN. THE CAS INFORMED THEM THAT THE IFU STATES THAT GPIIB/IIIA INHIBITOR AND HEPARIN SHOULD BE USED FOR THERAPY, AND WITHOUT A GPIIB/IIIA INHIBITOR, THE GOAL ACT SHOULD BE >300. THE THERAPY STARTED SUCCESSFULLY WITH 7FR. SINGLE ACCESS FEMORAL APPROACH AND JL4 THEROX CATHETER (LOT 196368) AND THE DOWNSTREAM CONSOLE (SN (B)(6). PRIOR TO INITIATION OF SSO2 THERAPY, NO THROMBUS WAS DETECTED ON THE ANGIOGRAPHY. AFTER THERAPY WAS COMPLETED, DR. (B)(6) CALLED AND NOTIFIED ZOLL THAT THE PATIENT RE-THROMBOSED IN STENT. THE THROMBUS WAS NOTED ON ANGIOGRAM IMMEDIATELY FOLLOWING SSO2 COMPLETION. HE SAID ACT WAS BETWEEN 270-280 THROUGHOUT THERAPY. THE DWELL TIME WAS 60 MINUTES. ADDITIONAL CATHETERIZATION LAB INTERVENTION WAS REQUIRED TO REMOVE THE THROMBUS POST-THERAPY. NO VESSEL INJURY WAS REPORTED. THE PATIENT IS STABLE AT THIS TIME.

    Description of Event or Problem · 0

    THE STAFF CALLED THE ZOLL CAS (CLINICAL ACCOUNT SPECIALIST) FOR SET-UP AND INITIATION OF SSO2 THERAPY AFTER PCI (PERCUTANEOUS CORONARY INTERVENTION) TO THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. DURING THE CALL, THE STAFF INFORMED ZOLL THAT THE ACTIVATED CLOTTING TIME (ACT) WAS 269 AFTER 14,000 UNITS OF HEPARIN. THE CAS INFORMED THEM THAT THE IFU STATES THAT GPIIB/IIIA INHIBITOR AND HEPARIN SHOULD BE USED FOR THERAPY, AND WITHOUT A GPIIB/IIIA INHIBITOR, THE GOAL ACT SHOULD BE >300. THE THERAPY STARTED SUCCESSFULLY WITH 7FR. SINGLE ACCESS FEMORAL APPROACH AND JL4 THEROX CATHETER (LOT: 196368). PRIOR TO INITIATION OF SSO2 THERAPY, NO THROMBUS WAS DETECTED ON THE ANGIOGRAPHY. AFTER THERAPY WAS COMPLETED, DR. (B)(6) CALLED AND NOTIFIED ZOLL THAT THE PATIENT RE-THROMBOSED IN STENT. THE THROMBUS WAS NOTED ON ANGIOGRAM IMMEDIATELY FOLLOWING SSO2 COMPLETION. HE SAID ACT WAS BETWEEN 270-280 THROUGHOUT THERAPY. THE DWELL TIME WAS 60 MINUTES. ADDITIONAL CATHETERIZATION LAB INTERVENTION WAS REQUIRED TO REMOVE THE THROMBUS POST-THERAPY. NO VESSEL INJURY WAS REPORTED. THE PATIENT IS STABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679429 DOWNSTREAM SYSTEM SUPERSATURATED OXYGEN THERAPY SYSTEM MWG THEROX, INC. DS-2 196368

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other| R