BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DECANAV

    MDR report key: 21974568 · Received May 7, 2025

    Report

    Report Number
    2029046-2025-01457
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    April 9, 2025
    Report Date
    May 7, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835008807
    PMA / PMN Number
    K080425
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31441818M AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. 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

    THE REPORT INDICATED THAT AFTER CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF A DECANAV CATHETER, THE PATIENT EXPERIENCED DECREASED BLOOD PRESSURE, PERICARDIAL EFFUSION (NO DRAINAGE PERFORMED BUT MEDICATION WAS PROVIDED). AFTER THE PROCEDURE, THE PATIENT'S BLOOD PRESSURE DECREASED, AND CARDIAC TAMPONADE WAS SUSPECTED. PERICARDIAL EFFUSION ACCUMULATION (NO DRAINAGE PERFORMED), AND THE ISSUE WAS NOT RESOLVED. NO EXTENDED HOSPITALIZATION WAS REQUIRED. THE PHYSICIAN'S OPINION ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT THERE WAS A POSSIBILITY THAT EXCESSIVE PRESSURE WAS APPLIED DURING THE LEFT VENTRICULAR (LV) MAP WITH DECANAV CATHETER. THERE WERE NO ABNORMALITIES OBSERVED PRIOR TO OR DURING USE OF THE PRODUCTS. ADDITIONAL INFORMATION RECEIVED INDICATED THAT NO DRAINAGE WAS PERFORMED. MEDICATION ADMINISTERED WERE NOREPINEPHRINE AND FLUID SUPPLY. THE PATIENT RECOVERED. DURING THE PROCEDURE, ONE CATHETER EXCHANGE WAS USED FOR EACH AREA, AND ONE TRANSSEPTAL PUNCTURE SITE WAS PERFORMED DURING THE PROCEDURE. THE PROCEDURAL ACTIVATED CLOTTING TIME (ACT) WAS 350-400 SECONDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1872778 DECANAV CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31441818M 10846835008807

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention NGEN PUMP, JAPAN CONFIGURATION| NGEN REMOTE MONITOR, JAPAN| QDOT MICRO, BI, TC, D-F| SOUNDSTAR ECO SMS 8F CATHETER