BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IMPULSETM CATHETER

    MDR report key: 16544144 · Received March 15, 2023

    Report

    Report Number
    2030964-2023-00002
    Event Type
    Injury
    Date Received
    March 15, 2023
    Date of Event
    February 19, 2023
    Report Date
    March 15, 2023
    Manufacturer
    THEROX INC
    Product Code
    DQO
    UDI-DI
    00862478000438
    PMA / PMN Number
    P170027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE THEROX SSO2 CATHETER INVOLVED IN THE REPORTED COMPLAINT WILL NOT BE RETURNED FOR EVALUATION BECAUSE NO DEVICE MALFUNCTION WAS REPORTED, AND THE DEVICE FUNCTIONED AS INTENDED DURING THE CLINICAL USE. THE TREATMENT WAS DISCUSSED IN DETAIL WITH THE CUSTOMER BY ZOLL THEROX SALES PERSONNEL. THE EVENT LOG FOR THE CONSOLE USED DURING THE SSO2 THERAPY WAS DOWNLOADED AND REVIEWED. BASED ON THE EVENT LOG, THE FIRST CARTRIDGE HAD A FLOW MEASUREMENT OUT-OF-RANGE ERROR ERR CODE 42 (SSO2 SOLUTION FLOW OUT OF RANGE) WHEN SSO2 THERAPY WAS INITIATED. A SECOND CARTRIDGE WAS ATTEMPTED AND THE CASE WAS COMPLETED SUCCESSFULLY FROM THE DEVICE STANDPOINT, NO FURTHER ISSUES AS CONFIRMED FROM THE LOG FILE. THE DEVICE WAS SUCCESSFULLY RECALIBRATED TO ADDRESS ERR CODE 42. 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. BASED ON ALL AVAILABLE INFORMATION AND MEDDEV DEFINITIONS, EVENT COULD BE ASSESSED AS POSSIBLY RELATED TO THEROX DEVICE AND SSO2 PROCEDURE WITH THIS DEVICE. DEFINITION OF UNLIKELY: "THE RELATIONSHIP WITH THE USE OF THE INVESTIGATIONAL DEVICE OR PROCEDURE IS WEAK BUT CANNOT BE RULED OUT COMPLETELY. ALTERNATIVE CAUSES ARE ALSO POSSIBLE (E.G. AN UNDERLYING OR CONCURRENT ILLNESS/ CLINICAL CONDITION OR/AND AN EFFECT OF ANOTHER DEVICE, DRUG OR TREATMENT). CASES WHERE RELATEDNESS CANNOT BE ASSESSED, OR NO INFORMATION HAS BEEN OBTAINED SHOULD ALSO BE CLASSIFIED AS POSSIBLE". THE EVENT IS ANTICIPATED AND IS "POSSIBLY" RELATED TO THE DEVICE AND PROCEDURE.

    Description of Event or Problem · 0

    ON (B)(6) 2023, A FEMALE PATIENT WAS ADMITTED WITH ANTERIOR ST-ELEVATION MYOCARDIAL INFARCTION (STEMI). THE PATIENT HAD A HISTORY OF A PRIOR MYOCARDIAL INFARCTION (MI) WITH A STENT PLACED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY, BUT THE DATE OF THE PREVIOUS MI WAS UNKNOWN. THE PATIENT HAD A HISTORY OF NON-COMPLIANCE WITH MEDICATION FOLLOWING A PREVIOUS PERCUTANEOUS CORONARY INTERVENTION (PCI). AN ANGIOGRAM WAS PERFORMED ON (B)(6) 2023, WHICH REVEALED THAT THE PREVIOUSLY IMPLANTED STENT IN THE LAD WAS OCCLUDED. AFTER REMOVING THE THROMBUS, AN ADDITIONAL STENT WAS PLACED SUCCESSFULLY. THE FL 4.0 DELIVERY CATHETER (LOT# UNKNOWN) WAS UTILIZED FOR SSO2 THERAPY. THROUGHOUT THE PROCEDURE, THE PATIENT RECEIVED INTRA-AORTIC HEPARIN AND IV CANGRELOR IN BOLUS AND DRIP FORMS, WITH ACTIVATED CLOTTING TIME (ACT) LEVELS KEPT ABOVE 250 EVERY 10-15 MINUTES. THE PHYSICIAN USED A MANUAL ASPIRATION CATHETER TO REMOVE IN-STENT THROMBOSIS, RE-ESTABLISHING CORONARY FLOW, AND OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS UTILIZED PRE AND POST STENTING TO CONFIRM STENT WALL APPOSITION. THE PATIENT REMAINED ON HEPARIN AND IV CANGRELOR THROUGHOUT THE SSO2 PROCEDURE AND FOR AN ADDITIONAL TWO HOURS AFTER LEAVING THE CATH LAB. THE SSO2 CATHETER REMAINED IN PLACE DURING THE 60-MINUTE THERAPY, AS WELL AS AN ADDITIONAL 2-5 MINUTES FOR PRE-INFUSION PLACEMENT AND FOLLOW-UP ANGIOGRAM AFTER SSO2 THERAPY. THE CATHETER DID NOT CAUSE ANY VISIBLE OR NOTED VESSEL INJURY. AFTER THE SUCCESSFUL DELIVERY OF SSO2 THERAPY, THE PATIENT WAS TRANSPORTED TO THE CARDIAC UNIT. HOWEVER, APPROXIMATELY THREE HOURS LATER, THE PATIENT EXPERIENCED CLINICAL SYMPTOMS SUGGESTING RE-INFARCTION, AND AN ELECTROCARDIOGRAM (ECG) REVEALED ACUTE STEMI. THE PATIENT WAS BROUGHT BACK TO THE CATH LAB, WHERE THE SAME STENT IN THE LAD WAS FOUND TO BE 100% OCCLUDED AGAIN. THE PHYSICIAN USED A MANUAL ASPIRATION CATHETER TO REMOVE THE THROMBOSIS FROM THE LAD STENT AND CONFIRMED STENT WALL APPOSITION USING OCT BEFORE AND AFTER STENTING. AN ADDITIONAL STENT WAS PLACED FOLLOWING THE REMOVAL OF THE THROMBUS. THE DAY AFTER HER PROCEDURE, THE PATIENT LEFT THE HOSPITAL DESPITE MEDICAL ADVICE TO STAY (AMA). THE PHYSICIAN BELIEVES IT'S HIGHLY IMPROBABLE THAT THE PATIENT WILL COME BACK FOR ANY FURTHER FOLLOW-UP APPOINTMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1037377 IMPULSETM CATHETER CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO THEROX INC SSO2 - 4.0 UNKNOWN 00862478000438

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other