BEUDAMED
    FDA Adverse Event Death Summary report: N

    THEROX DOWNSTREAM SSO2 CATHETER DSC-2

    MDR report key: 24145442 · Received January 22, 2026

    Report

    Report Number
    MW5182624
    Event Type
    Death
    Date Received
    January 22, 2026
    Date of Event
    December 16, 2025
    Report Date
    January 16, 2026
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    MWG
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    A 47 Y/O SPANISH-SPEAKING MALE FROM GUATEMALA PRESENTS TO ED AT 7:34 A.M. WITH 10/10 CHEST PAIN, NAUSEA AND DIAPHORESIS WHICH BEGAN AT 6 A.M. IN THE MORNING. PATIENT HAS HISTORY OF HTN AND LEFT LEG DVT (DEEP VEIN THROMBOSIS) FOR WHICH HE TAKES AN UNKNOWN ANTICOAGULANT (LATER DOCUMENTED AS XARELTO) THAT WAS GIVEN TO HIM BY A DOCTOR IN GUATEMALA. LAST DOSE WAS 4 P.M. ON THE DAY BEFORE ADMISSION. INITIAL EKG IN THE ED WAS WITHOUT EVIDENCE OF ACUTE MYOCARDIAL INFARCTION. SUBSEQUENT ED EKG SHOWED ANTEROLATERAL ST ELEVATIONS WITH RECIPROCAL ST DEPRESSIONS. ASPIRIN 324 MG PO, TICAGRELOR 180 MG PO, ATORVASTATIN 80 MG PO WERE GIVEN AND THE PATIENT WAS TAKEN EMERGENTLY TO THE CATH LAB. CARDIAC CATH WAS PERFORMED WHICH SHOWED A 50% LEFT MAIN LESION, 100% OSTIAL TO MID LAD LESION, 100% RCA CTO WITH R->R COLLATERALS, 80% CIRCUMFLEX LESION. LVEF (LEFT VENTRICULAR EJECTION FRACTION) WAS 20-25%. PCI OF THE LAD WAS BEGUN WITH HEPARIN ALONE WITHOUT GPIIB/IIIA FOR ANTICOAGULATION. UPON CROSSING THE LESION WITH AN INTERVENTIONAL GUIDEWIRE, THE MONITOR SHOWED VENTRICULAR FIBRILLATION AND THE PATIENT WAS DEFIBRILLATED TO NSR. THE PATIENT WAS SUBSEQUENTLY INTUBATED AND STENT PLACEMENT FOLLOWED BY THROMBECTOMY WERE SUCCESSFULLY PERFORMED IN THE LAD. NEXT, THE PATIENT RECEIVED THEROX SUPERSATURATED OXYGEN THERAPY FOR 60 MINUTES. ACT (ACTIVATED CLOTTING TIME) RESULT JUST PRIOR TO INITIATING THEROX WAS 286 SECONDS AND A HEPARIN 1000 UNIT BOLUS WAS GIVEN. TWENTY MINUTES AFTER INITIATION, THE ACT RESULT WAS 241 SECONDS AND A HEPARIN BOLUS OF 4000 UNITS WAS GIVEN. THE SUBSEQUENT ACT RESULTS BEFORE STOPPING THEROX WERE 336 AND 303 SECONDS. IMMEDIATELY AFTER SUPER-SATURATED OXYGEN THERAPY, ANGIOGRAPHY REVEALED AN OCCLUDED LAD AND THROMBUS IN THE DISTAL CIRCUMFLEX AND LEFT MAIN. ACT MEASURED 241 SECONDS 12 MINUTES POST STOPPAGE. EPTIFIBATIDE BOLUS X2 AND IV DRIP WERE STARTED AND IMPELLA WAS INSERTED. THROMBECTOMY AND POBA (PLAIN OLD BALLOON ANGIOPLASTY) IN THE LAD WERE THEN PERFORMED AND A STENT WAS PLACED IN THE PROXIMAL CIRCUMFLEX ARTERY SUCCESSFULLY. POST-PROCEDURE, THE PATIENT REQUIRED 15 DAYS OF TREATMENT IN THE CRITICAL CARE UNITS AND THEN WAS DOWNGRADED TO TELEMETRY. THE PATIENT REMAINED ON TELEMETRY FOR 8 DAYS AND DISCHARGED WAS ANTICIPATED, HOWEVER, THE PATIENT SUFFERED CARDIAC ARREST AND WAS UNABLE TO BE RESUSCITATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204205 THEROX DOWNSTREAM SSO2 CATHETER DSC-2 SYSTEM, OXYGEN, AQUEOUS MWG ZOLL CIRCULATION, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Male Death| R| L| H ASPIRIN 324 MG PO | ATORVASTATIN 80| TICARETOR 180 MG PO| XARELTO