BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV

    MDR report key: 23032033 · Received September 11, 2025

    Report

    Report Number
    2029046-2025-03109
    Event Type
    Malfunction
    Date Received
    September 11, 2025
    Date of Event
    August 15, 2025
    Report Date
    October 7, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION TO INITIAL CONCOMITANT PRODUCT WAS NOT INCLUDED. SECTION D10. HAS BEEN UPDATED. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REF. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT YET BEEN RETURNED FOR ANALYSIS. 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. NO: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION ON 12-SEP-2025. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A PENTARAY NAV CATHETER AND AFTER THE PULMONARY VEIN ISOLATION WAS COMPLETED, WHEN THE CATHETER, WHICH WAS ONCE OUTSIDE OF THE PATIENT, WAS ATTEMPTED TO BE REINSERTED, THE SALINE SOLUTION DID NOT IRRIGATE FROM THE IRRIGATION HOLES. DEVICE INVESTIGATION DETAILS: FOLLOWING J&J MEDTECH PROCEDURES, A VISUAL INSPECTION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED. VISUAL INSPECTION REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. AN IRRIGATION TEST WAS PERFORMED, AND THE CATHETER FAILED THE TEST DUE TO THE IRRIGATION TUBE WAS FOUND FOLDED AT THE TIP AREA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH NUMBER, AND NO INTERNAL ACTIONS WERE IDENTIFIED. THE IRRIGATION ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE ROOT CAUSE OF THE IRRIGATION TUBE FOLDED WAS TRACED TO THE MANUFACTURING PROCESS. THE INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING INFORMATION: FLUSH THE CATHETER WITH HEPARINIZED SALINE PRIOR TO INSERTION INTO THE BODY. ALWAYS FOLLOW STANDARD PRACTICES OF USING A CONTINUOUS DRIP OF ANTICOAGULANT FLUID UNDER PRESSURE THROUGH THE PROXIMAL LUER CONNECTOR WHEN THE DEVICE IS IN THE BODY. AS PART OF THE JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. AN INTERNAL CORRECTIVE ACTION WAS CREATED TO INVESTIGATE THIS ISSUE. IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A PENTARAY NAV CATHETER AND AFTER THE PULMONARY VEIN ISOLATION WAS COMPLETED, WHEN THE CATHETER, WHICH WAS ONCE OUTSIDE OF THE PATIENT, WAS ATTEMPTED TO BE REINSERTED, THE SALINE SOLUTION DID NOT IRRIGATE FROM THE IRRIGATION HOLES. SALINE SOLUTION WAS PUSHED IN FROM THE SYRINGE AND THE CATHETER DID NOT IRRIGATE. THE ISSUE WAS RESOLVED BY REPLACING THE CATHETER WITH ANOTHER NEW ONE. THE PROCEDURE WAS COMPLETED WITHOUT PATIENT CONSEQUENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2202742 PENTARAY NAV CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31571507L 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown SMARTABLATE PUMP KIT (JAPAN).