BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OCTARAY MAPPING CATHETER

    MDR report key: 21972591 · Received May 6, 2025

    Report

    Report Number
    2029046-2025-01447
    Event Type
    Malfunction
    Date Received
    May 6, 2025
    Date of Event
    April 14, 2025
    Report Date
    June 2, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835021233
    PMA / PMN Number
    K193237
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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 REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    ON 8-MAY-2025, THE BWI PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE PRODUCT INVESTIGATION WAS SUBSEQUENTLY COMPLETED. IT WAS REPORTED THAT A PATIENT UNDERWENT AN ATRIAL FIBRILLATION ABLATION PROCEDURE WITH A OCTARAY MAPPING CATHETER AND AFTER SOME ABLATION HAD BEEN COMPLETED, AND THE MEDICAL TEAM HAD RE-INSERTED THE OCTARAY¿ CATHETER INTO THE BODY, IT WAS NOTICED THAT THE TIP OF THE OCTARAY¿ CATHETER WAS NOT IRRIGATING. THE CATHETER WAS REMOVED FROM THE BODY AND FLUSHING WAS PERFORMED WITH A SYRINGE. HOWEVER, THE CATHETER WAS OCCLUDED AND NO SOLUTION CAME OUT. THE DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED. DEVICE EVALUATION DETAILS: THE DEVICE WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J) FOR EVALUATION. A VISUAL INSPECTION EVALUATION AND IRRIGATION TEST OF THE RETURNED DEVICE WAS PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL INSPECTION OF THE RETURNED SAMPLE REVEALED NO DAMAGE OR ANOMALIES. AN IRRIGATION TEST WAS PERFORMED AND THE DEVICE WAS TOTALLY OCCLUDED. FURTHER INVESTIGATION REVEALED THAT THE IRRIGATION TUBE WAS FOUND FOLDED IN THE TIP AREA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31532293L NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED. THE IRRIGATION ISSUE REPORTED BY THE CUSTOMER WAS CONFIRMED. THE POTENTIAL CAUSE OF THE OCCLUSION COULD BE RELATED TO THE MANIPULATION OF THE DEVICE DURING THE PROCEDURE; HOWEVER, THIS CAN NOT BE CONCLUSIVELY DETERMINED. THE CATHETER INSTRUCTIONS FOR USE (IFU) CONTAIN THE FOLLOWING RECOMMENDATIONS: FLUSH THE CATHETER WITH HEPARINIZED NORMAL SALINE PRIOR TO INSERTION INTO THE BODY. AS PART OF THE JOHNSON & JOHNSON MEDTECH QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH J&J MEDTECH QUALITY SYSTEM. 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 OCTARAY MAPPING CATHETER AND AFTER SOME ABLATION HAD BEEN COMPLETED, AND THE MEDICAL TEAM HAD RE-INSERTED THE OCTARAY¿ CATHETER INTO THE BODY, IT WAS NOTICED THAT THE TIP OF THE OCTARAY¿ CATHETER WAS NOT IRRIGATING. THE CATHETER WAS REMOVED FROM THE BODY AND FLUSHING WAS PERFORMED WITH A SYRINGE. HOWEVER, THE CATHETER WAS OCCLUDED AND NO SOLUTION CAME OUT. THE DEVICE WAS REPLACED AND THE ISSUE WAS RESOLVED. THE PROCEDURE CONTINUED. NO PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99545 OCTARAY MAPPING CATHETER CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31532293L 10846835021233

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown FARAPULSE SYSTEM.