BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER

    MDR report key: 15667518 · Received October 25, 2022

    Report

    Report Number
    2029046-2022-02624
    Event Type
    Injury
    Date Received
    October 25, 2022
    Date of Event
    April 21, 2022
    Report Date
    October 25, 2022
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. GAGYI RB, NOTEN AME, WIJCHERS S, YAP SC, BHAGWANDIEN RE, HOOGENDIJK MG, SZILI-TOROK T. DIPOLE CHARGE DENSITY MAPPING INTEGRATED IN REMOTE MAGNETIC NAVIGATION: FIRST-IN-HUMAN FEASIBILITY STUDY. INT J CARDIOL HEART VASC. 2022 JUL 21;42:101095. DOI: 10.1016/J.IJCHA.2022.101095. PMID: 35899072; PMCID: PMC9309500. SINCE NO DEVICE HAS BEEN RECEIVED FOR ANALYSIS, NO PRODUCT INVESTIGATION CAN BE PERFORMED, AND THE CUSTOMER COMPLAINT CANNOT BE CONFIRMED. MANUFACTURING RECORD EVALUATION (MRE) CANNOT BE CONDUCTED BECAUSE NO LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. GAGYI RB, NOTEN AME, WIJCHERS S, YAP SC, BHAGWANDIEN RE, HOOGENDIJK MG, SZILI-TOROK T. DIPOLE CHARGE DENSITY MAPPING INTEGRATED IN REMOTE MAGNETIC NAVIGATION: FIRST-IN-HUMAN FEASIBILITY STUDY. INT J CARDIOL HEART VASC. 2022 JUL 21;42:101095. DOI: 10.1016/J.IJCHA.2022.101095. PMID: 35899072; PMCID: PMC9309500. OBJECTIVE/METHODS/STUDY DATA: THE AIM OF THIS FIRST-IN-HUMAN EXPERIENCE STUDY WAS TO COMPARE SAFETY, EFFICIENCY, AND EFFICACY OF ACQMAP-RMN INTEGRATION IN CA ABLATION PROCEDURES WITH CARTO-RMN MAPPING FOR PATIENTS WITH ATRIAL FIBRILLATION (AF) AND ATRIAL TACHYCARDIAS (ATS). IN THIS PROSPECTIVE REGISTRY, PROCEDURAL SAFETY EFFICIENCY AND OUTCOME DATA FROM TOTAL OF 238 CONSECUTIVE PATIENTS (147 ACQMAP-RMN AND 91 CARTO-RMN PATIENTS) WERE COMPARED. PROCEDURES FROM BOTH THE STUDY AND CONTROL PATIENT POPULATION WERE PERFORMED DURING THE SAME INCLUSION PERIOD (BETWEEN MARCH OF 2018 AND DECEMBER OF 2021), BY THE SAME GROUP OF SENIOR ELECTROPHYSIOLOGISTS, AND THERE WERE NO DIFFERENCES REGARDING ANY DEMOGRAPHIC DATA. THE INCLUSION CRITERIA WERE DOCUMENTED AF OR AT ON ECG, HOLTER MONITORING, OR PREVIOUS CA PROCEDURE WITH DOCUMENTED RECURRENCES. LOT, MODEL AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BIOSENSE DEVICE POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: 4-MM TIP NAVISTAR RMT THERMOCOOL ABLATION CATHETER. OTHER BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: CARTO. NON-BIOSENSE WEBSTER DEVICES THAT WERE ALSO USED IN THIS STUDY: MAPPING CATHETER (ACQMAP CATHETER, ACUTUS MEDICAL, CARLSBAD, CA), 15F DEFLECTABLE SHEATH (ACQGUIDE SHEATH, ACUTUS MEDICAL,CARLSBAD, CA), MAGNOFLUSH (MEDFACT, GERMANY) ABLATION CATHETER, AGILIS NXT FR 8.5 MEDIUM CURVE SHEATH , ABLATION CATHETERS (MAGNOFLUSH FOR ACQMAP, AND NAVISTAR RMT FOR CARTO). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS: QTY 1 PHRENIC NERVE INJURY WITH LONG-STANDING DIAPHRAGM PARALYSIS- NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2920954 NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER CATHETER, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other 15F DEFLECTABLE SHEATH (ACQGUIDE SHEATH)| ABLATION CATHETERS (MAGNOFLUSH FOR ACQMAP)| ABLATION CATHETERS (NAVISTAR RMT FOR CARTO)| AGILIS NXT FR 8.5 MEDIUM CURVE SHEATH| CARTO| MAGNOFLUSH (MEDFACT, GERMANY) ABLATION CATHETER| MAPPING CATHETER (ACQMAP CATHETER, ACUTUS MEDICAL)