BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PENTARAY NAV

    MDR report key: 22116988 · Received May 30, 2025

    Report

    Report Number
    2029046-2025-01755
    Event Type
    Injury
    Date Received
    May 30, 2025
    Date of Event
    May 5, 2025
    Report Date
    June 26, 2025
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    MTD
    UDI-DI
    10846835012224
    PMA / PMN Number
    K123837
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOSENSE WEBSTER, INC. PRODUCT ANALYSIS LAB RECEIVED THE DEVICE FOR EVALUATION. THE ANALYSIS HAS BEGUN BUT IS NOT COMPLETED AT THIS TIME. WHEN THE INVESTIGATIONAL ANALYSIS HAS BEEN COMPLETED, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED. 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

    THE REPORT INDICATED THAT DURING A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS. THE PATIENT SUFFERED A PERICARDIAL EFFUSION DURING A FARAPULSE PULSED FIELD ABLATION (PFA) PROCEDURE. THE PENTARAY NAV CATHETER WAS USED TO MAP THE RIGHT AND LEFT ATRIA. THE PATIENT WAS STABLE, NON-SYMPTOMATIC THROUGHOUT THE PROCEDURE. AT THE END OF THE CASE, WHILE USING INTRACARDIAC ECHO (SOUNDSTAR CATHETER), A MODERATE EFFUSION WAS NOTICED. THE PHYSICIAN CALLED FOR A TRANSTHORACIC ECHO TO CONFIRM THE EFFUSION. A PERICARDIOCENTESIS WAS IN PROGRESS AT THE TIME OF THE CALL. THE PATIENT WAS STABLE. IT WAS UNKNOWN WHEN OR HOW THE EFFUSION OCCURRED. THE TRANSSEPTAL ACCESS PUNCTURE WAS SOMEWHAT ANTERIOR, AND IT WAS MENTIONED THAT THE FARAWAVE CATHETER WAS ¿MOVED AROUND THE LEFT ATRIAL (LA) KIND OF QUICKLY¿. DEVICE INVESTIGATION DETAILS: THE PRODUCT WAS RETURNED TO JOHNSON & JOHNSON MEDTECH (J&J MEDTECH) FOR EVALUATION. A VISUAL INSPECTION AND REVISION OF ALL FEATURES WERE PERFORMED FOLLOWING J&J MEDTECH PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. THE DEVICE FEATURES WERE REVIEWED, AND NO ISSUES WERE OBSERVED DURING THE PRODUCT INVESTIGATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31584698L AND NO INTERNAL ACTION RELATED TO THE COMPLAINT WAS FOUND DURING THE REVIEW. NO MALFUNCTION WAS OBSERVED DURING THE PRODUCT ANALYSIS. THE ROOT CAUSE OF THE ADVERSE EVENT REMAINS UNKNOWN. IN ADDITION, NO DEVICE MALFUNCTION WAS REPORTED. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT COULD NOT BE REPLICATED DURING THE ANALYSIS. NO ERROR MESSAGES WERE OBSERVED ON JOHNSON & JOHNSON MEDTECH EQUIPMENT DURING THE PROCEDURE. THE INSTRUCTION FOR USE (IFU) STATES THAT CAREFUL CATHETER MANIPULATION MUST BE PERFORMED TO AVOID CARDIAC DAMAGE, PERFORATION, OR TAMPONADE. 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

    THE REPORT INDICATED THAT DURING A CARDIAC ABLATION PROCEDURE WITH A PENTARAY NAV, THE PATIENT EXPERIENCED PERICARDIAL EFFUSION TREATED WITH PERICARDIOCENTESIS. THE PATIENT SUFFERED A PERICARDIAL EFFUSION DURING A FARAPULSE PULSED FIELD ABLATION (PFA) PROCEDURE. THE PENTARAY NAV CATHETER WAS USED TO MAP THE RIGHT AND LEFT ATRIA. THE PATIENT WAS STABLE, NON-SYMPTOMATIC THROUGHOUT THE PROCEDURE. AT THE END OF THE CASE, WHILE USING INTRACARDIAC ECHO (SOUNDSTAR CATHETER), A MODERATE EFFUSION WAS NOTICED. THE PHYSICIAN CALLED FOR A TRANSTHORACIC ECHO TO CONFIRM THE EFFUSION. A PERICARDIOCENTESIS WAS IN PROGRESS AT THE TIME OF THE CALL. THE PATIENT WAS STABLE. IT WAS UNKNOWN WHEN OR HOW THE EFFUSION OCCURRED. THE TRANSSEPTAL ACCESS PUNCTURE WAS SOMEWHAT ANTERIOR, AND IT WAS MENTIONED THAT THE FARAWAVE CATHETER WAS ¿MOVED AROUND THE LEFT ATRIAL (LA) KIND OF QUICKLY.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667909 PENTARAY NAV CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY MTD BIOSENSE WEBSTER INC 31584698L 10846835012224

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| L BSX FARAPULSE PFA SYSTEM.| CARTO 3 SYSTEM.| FARAWAVE CATHETER.| UNK_SOUNDSTAR ECO.