BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV ECO 7FR, F, 2-6-2

    MDR report key: 22379542 · Received July 1, 2025

    Report

    Report Number
    2029046-2025-02154
    Event Type
    Malfunction
    Date Received
    July 1, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012224
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 REF. # (B)(4).

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV AND AN IRRIGATION ISSUE OCCURRED. AT THE BEGINNING OF THE PROCEDURE, THE PENTARAY NAV¿S IRRIGATION WAS WORKING VERY WELL AND WAS SET AT 2 ML/MIN APPROXIMATELY. AFTER THE FIRST MAPPING IN THE LEFT ATRIUM, THE PHYSICIAN WITHDREW THE PENTARAY NAV TO INSERT THE ABLATION CATHETER. WHILE THE PENTARAY NAV WAS OUTSIDE OF THE BODY, THE NURSE NOTICED THAT THE FLOW WAS STILL SET CORRECTLY BUT THE PENTARAY NAV WAS NOT IRRIGATING ANYMORE. DEVICE INVESTIGATION DETAILS: AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. HOWEVER, IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER 31624658L 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. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. #: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV AND AN IRRIGATION ISSUE OCCURRED. AT THE BEGINNING OF THE PROCEDURE, THE PENTARAY NAV¿S IRRIGATION WAS WORKING VERY WELL AND WAS SET AT 2ML/MIN APPROXIMATELY. AFTER THE FIRST MAPPING IN THE LEFT ATRIUM, THE PHYSICIAN WITHDREW THE PENTARAY NAV TO INSERT THE ABLATION CATHETER. WHILE THE PENTARAY NAV WAS OUTSIDE OF THE BODY, THE NURSE NOTICED THAT THE FLOW WAS STILL SET CORRECTLY BUT THE PENTARAY NAV WAS NOT IRRIGATING ANYMORE. THE PHYSICIAN TRIED TO UNBLOCK IT WITH A SYRINGE, BUT NOTHING WORKED, WE HAD TO REPLACE THE PENTARAY NAV AND CONTINUE WITH A NEW ONE. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1297277 PENTARAY NAV ECO 7FR, F, 2-6-2 CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31624658L 10846835012224

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown