BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PENTARAY NAV

    MDR report key: 25156623 · Received May 12, 2026

    Report

    Report Number
    2029046-2026-01560
    Event Type
    Malfunction
    Date Received
    May 12, 2026
    Date of Event
    April 4, 2026
    Report Date
    May 12, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012255
    PMA / PMN Number
    K123837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. VISUAL INSPECTION AND IRRIGATION TEST OF THE RETURNED DEVICE WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED THAT THE SHAFT WAS BENT. AN IRRIGATION TEST WAS PERFORMED, AND THE CATHETER FAILED THE TEST SINCE THE IRRIGATION TUBE WAS FOUND BENT INSIDE THE SHAFT, AT THE SAME LOCATION WHERE THE SHAFT WAS FOUND BENT. 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 DUE TO THE BENT IRRIGATION TUBE. THE POTENTIAL CAUSE OF THE IRRIGATION TUBE BENT, COULD BE RELATED TO THE BENT ON THE SHAFT OF THE DEVICE; THE POTENTIAL CAUSE OF THE BENT SHAFT, COULD NOT BE DETERMINED. THE INSTRUCTIONS FOR USE CONTAIN THE FOLLOWING RECOMMENDATIONS: FLUSH THE CATHETER WITH HEPARINIZED NORMAL SALINE PRIOR TO INSERTION INTO THE BODY AND ENSURE THAT SALINE FLOWS THROUGH THE DISTAL END OF THE IRRIGATION LUMEN. AS PART OF JOHNSON & JOHNSON MEDTECH'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED 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

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A PENTARAY NAV AND DURING THE OPERATION, DEVICE (INCLUDING PORT, LUER HUB) WAS NOT IRRIGATING. A SECOND DEVICE WAS USED TO COMPLETE THE OPERATION. THERE WAS NO ADVERSE EVENT REPORTED ON THE PATIENT. WITH THE INITIAL INFORMATION PRESENTED, THIS EVENT WAS ASSESSED AS NOT MDR REPORTABLE. HOWEVER, ON 15- APR-2026, ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE SUSPECTED DEVICE FOR THE IRRIGATION ISSUE WAS THE CATHETER AND THAT THE DEVICE WAS USED ON THE PATIENT. THIS MADE THE EVENT MDR REPORTABLE WITH AN AWARENESS DATE OF 15-APR-2026. IT WAS ALSO INDICATED THAT A NGEN PUMP WAS USED FOR THIS CASE AND NO ERROR WAS NOTED ON THE PUMP. VISUAL OBSERVATION SHOWS THAT THE SALTWATER HOLE IN THE CONDUIT IS NOT SPRAYING SMOOTHLY. TO RESOLVE THE ISSUE, THEY TRIED HIGH FLOW RATE, STRONG DISCHARGE, AND HAND BOUNCING THE CATHETER TIP. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. THERE WERE NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    225783 PENTARAY NAV CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31764450L 10846835012255

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown