BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK_OCTARAY NAV

    MDR report key: 22813558 · Received August 15, 2025

    Report

    Report Number
    2029046-2025-02709
    Event Type
    Injury
    Date Received
    August 15, 2025
    Report Date
    August 15, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    PMA / PMN Number
    K193237
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A DATABASE RELATED RESEARCH ACTIVITY (DRRA). "DIFFERENCES IN HOSPITAL READMISSION AMONG PATIENTS WITH ATRIAL FIBRILLATION UNDERGOING ABLATION USING A NON-INTEGRATED PULSED FIELD CATHETER WITH CARTO¿ 3 VERSUS ENSITE¿ ELECTROANATOMICAL MAPPING SYSTEM." D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY BIOSENSE WEBSTER, INC., OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, BIOSENSE WEBSTER, INC. OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    A DATABASE RELATED RESEARCH ACTIVITY (DRRA) WAS RECEIVED REGARDING THE STUDY: ¿DIFFERENCES IN HOSPITAL READMISSION AMONG PATIENTS WITH ATRIAL FIBRILLATION UNDERGOING ABLATION USING A NONINTEGRATED PULSED FIELD CATHETER WITH CARTO¿ 3 VERSUS ENSITE¿ ELECTROANATOMICAL MAPPING SYSTEM¿. ADVERSE EVENTS REPORTED FOR OCTARAY: QTY 1 CARDIOVASCULAR RELATED INPATIENT READMISSION WITHIN 30 DAYS (INSUFFICIENT INFORMATION)(PROLONGED HOSPITALIZATION). QTY 1 ACUTE CORONARY SYNDROME (MYOCARDIAL INFARCTION)(PROLONGED HOSPITALIZATION) QTY 2: 1 ISCHEMIC STROKE, 1 HEMORRHAGIC STROKE (CEREBROVASCULAR ACCIDENT)(PROLONGED HOSPITALIZATION). QTY 1 THROMBOEMBOLISM (THROMBOSIS)(PROLONGED HOSPITALIZATION), QTY 1 TRANSIENT ISCHEMIC ATTACK (TRANSIENT ISCHEMIC ATTACK)(PROLONGED HOSPITALIZATION), QTY 1 PHRENIC NERVE DAMAGE (DIAPHRAGMATIC PARALYSIS)(PROLONGED HOSPITALIZATION), QTY 1 PERICARDITIS (PERICARDITIS) (PROLONGED HOSPITALIZATION), QTY 2 BLEEDING / BLOOD TRANSFUSION (BLEEDING)(PROLONGED HOSPITALIZATION), QTY 1 VAGAL NERVE INJURY (NERVE INJURY)(PROLONGED HOSPITALIZATION), QTY 1 CARDIAC TAMPONADE/PERFORATION (CARDIAC PERFORATION)(PROLONGED HOSPITALIZATION), QTY 1 HEMATURIA (HEMATURIA)(PROLONGED HOSPITALIZATION), QTY 1 ORGAN FAILURE (ORGAN FAILURE)(PROLONGED HOSPITALIZATION), QTY 1 ANEMIA (ANEMIA)(PROLONGED HOSPITALIZATION), QTY 1 ACUTE KIDNEY INJURY (ACUTE KIDNEY FAILURE)(PROLONGED HOSPITALIZATION), QTY 1 ACUTE HEART FAILURE (CARDIAC FAILURE)(PROLONGED HOSPITALIZATION), QTY 1 PULMONARY EDEMA (PULMONARY EDEMA)(PROLONGED HOSPITALIZATION), QTY 1 VASOVAGAL RESPONSE (SYNCOPE)(PROLONGED HOSPITALIZATION).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1300354 UNK_OCTARAY NAV CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization| R| L CARTO3 EXTERNAL REFPATCH 6PACK