BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SSO2 CATHETER 3.5

    MDR report key: 16469514 · Received March 2, 2023

    Report

    Report Number
    2030964-2023-00001
    Event Type
    Injury
    Date Received
    March 2, 2023
    Date of Event
    February 7, 2023
    Report Date
    March 24, 2023
    Manufacturer
    THEROX INC
    Product Code
    MWG
    UDI-DI
    10862478000442
    PMA / PMN Number
    P170027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE SSO2 CATHETER 3.5 ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. THE PRODUCT WAS DISPOSED BY THE CUSTOMER. SINCE THE DEVICE WAS NOT RETURNED, AN INVESTIGATION COULD NOT BE PERFORMED AND A ROOT CAUSE COULD NOT BE DETERMINED. EVENT WAS SERIOUS AS EVENT REQUIRED ADDITIONAL INTERVENTION. 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. BASED ON ALL AVAILABLE INFORMATION AND MEDDEV DEFINITIONS, EVENT COULD BE ASSESSED AS NOT RELATED TO THEROX DEVICE AND SSO2 PROCEDURE WITH THIS DEVICE BECAUSE THROMBUS OCCURRED IN A DIFFERENT VESSEL. THROMBUS IS ANTICIPATED EVENT AND COULD POTENTIALLY OCCUR POST PCI TREATMENT. THE REPORTED EVENT IS NOT RELATED TO THE DEVICE AND PROCEDURE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS TO PROVIDE CORRECTION ON THE ZOLL INTERPRETED PROBLEM, SECTION B5.

    Description of Event or Problem · 0

    A 69-YEARS-OLD MALE PATIENT (WEIGHT 100.5KG) EXPERIENCED STEMI, WAS ADMITTED AND UNDERWENT PCI AND SSO2 THERAPY. TARGET PCI LESION WAS IN LAD, STENT WAS PLACED IN THIS VESSEL. A SS02 CATHETER 3.5 (LOT #UNKNOWN) WAS USED FOR THERAPY, AND THERE WAS NO DIFFICULTY PLACING THE SSO2 CATHETER 3.5. JUST AFTER THE 60 MINUTES INFUSION, A THROMBUS WAS IDENTIFIED IN LEFT CIRCUMFLEX ARTERY. DURING HOSPITALIZATION THE PATIENT RECEIVED THE FOLLOWING ANTICOAGULATION THERAPY: PLAVIX AND ASPIRIN AND HEPARIN BEFORE AND DURING PCI, THEN CANGREL OR ONCE THROMBUS WAS DIAGNOSED AND THEN SWITCHED TO BRILINTA. ACTIVATED CLOTTING TIME (ACT) WERE MAINTAINED ABOVE 250 FOR THE DURATION OF THE INFUSION. PER PATIENT MEDICAL HISTORY, DISTANT MYOCARDIAL INFARCTION (MI) ALTHOUGH NOT ON MEDS; NO PRIOR HISTORY OF DIABETES MELLITUS (DM), HYPERTENSION (HTN), DYSLIPIDEMIA OR TOBACCO. WAXING AND WANING SYMPTOMS FOR ONE WEEK AND THEN PROLONGED SYMPTOMS FOR 10-12 HOURS. PLAVIX, ASPIRIN, AND HEPARIN ANTIPLATELET WERE USED BEFORE AND DURING PCI. CANGRELOR TREATMENT ONCE THROMBUS WAS DIAGNOSED, AND THEN SWITCHED TO BRILINTA. THROMBUS WAS REMOVED. NO CONSEQUENCES OR IMPACT TO THE PATIENT.

    Description of Event or Problem · 0

    A 69-YEARS-OLD MALE PATIENT (WEIGHT 100.5KG) EXPERIENCED STEMI, WAS ADMITTED AND UNDERWENT PCI AND SSO2 THERAPY. TARGET PCI LESION WAS IN LAD, STENT WAS PLACED IN THIS VESSEL. A SS02 CATHETER 3.5 (LOT #UNKNOWN) WAS USED FOR THERAPY, AND THERE WAS NO DIFFICULTY PLACING THE SSO2 CATHETER 3.5. JUST AFTER THE 60 MINUTES INFUSION, A THROMBUS WAS IDENTIFIED IN LEFT CIRCUMFLEX ARTERY. DURING HOSPITALIZATION THE PATIENT RECEIVED THE FOLLOWING ANTICOAGULATION THERAPY: PLAVIX AND ASPIRIN AND HEPARIN BEFORE AND DURING PCI, THEN CANGRELOR ONCE THROMBUS WAS DIAGNOSED AND THEN SWITCHED TO BRILINTA. ACTIVATED CLOTTING TIME (ACT) WERE MAINTAINED ABOVE 250 FOR THE DURATION OF THE INFUSION. PER PATIENT MEDICAL HISTORY, DISTANT MYOCARDIAL INFARCTION (MI) ALTHOUGH NOT ON MEDS; NO PRIOR HISTORY OF DIABETES MELLITUS (DM), HYPERTENSION (HTN), DYSLIPIDEMIA OR TOBACCO. WAXING AND WANING SYMPTOMS FOR ONE WEEK AND THEN PROLONGED SYMPTOMS FOR 10-12 HOURS. PLAVIX, ASPIRIN, AND HEPARIN ANTIPLATELET WERE USED BEFORE AND DURING PCI. CANGRELOR TREATMENT ONCE THROMBUS WAS DIAGNOSED, AND THEN SWITCHED TO BRILINTA. THROMBUS WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1913508 SSO2 CATHETER 3.5 SYSTEM, OXYGEN, AQUEOUS MWG THEROX INC SSO2 CATHETER 3.5 UNKNOWN 10862478000442

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other