BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO NAV

    MDR report key: 24446294 · Received February 25, 2026

    Report

    Report Number
    2029046-2026-00642
    Event Type
    Injury
    Date Received
    February 25, 2026
    Date of Event
    February 2, 2026
    Report Date
    March 24, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    PMA / PMN Number
    K113213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01)GTIN IS NOT AVAILABLE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. AN EVALUATION OF THE MANUFACTURING RECORD COULD NOT BE PERFORMED AS THE REQUIRED PRODUCT IDENTIFICATION NUMBER WAS NOT PROVIDED TO COMPLETE THE EVALUATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED TO APPROVED SPECIFICATIONS. BASED ON THE INFORMATION AVAILABLE, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. IF THE PRODUCT IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    ADDITIONAL INFORMATION WAS RECEIVED ON 26-FEB-2026 WHICH INDICATED THAT AN ABBOTT BRK AND FARADRIVE SHEATH WERE USED FOR THE TRANSSEPTAL PROCEDURE. 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 (AFIB) PROCEDURE WITH A LASSO NAV CATHETER AND THE PATIENT EXPERIENCED AN AIR BUBBLE WHICH MAY HAVE ENTERED IN THE CORONARY ARTERY, PERSISTENT VENTRICULAR FIBRILLATION REQUIRING CHEST COMPRESSIONS, DEFIBRILLATION, MEDICATIONS AND STAYED IN THE HOSPITAL FOR OBSERVATION. DURING A CTI FLUTTER WITH AN 8MM RF CATHETER, THEY WENT TRANSSEPTAL AND WERE MAPPING WITH A LASSO NAV CATHETER. THE CATHETER WAS REMOVED FROM THE BODY TO BE CHECKED AND THEN RE-ADVANCED FOR A SECOND TRANSSEPTAL. THEY WERE MAPPING FOR ABOUT 2 MINUTES AFTER TRANSSEPTAL, AND THE PATIENT WENT INTO PERSISTENT VENTRICULAR FIBRILLATION. THE PHYSICIAN STATED THEY BELIEVED DURING THE 2ND TRANSSEPTAL A BUBBLE MAY HAVE ENTERED THE CORONARY. AN ANGIOGRAM WAS PERFORMED. THE PATIENT WAS GIVEN CHEST COMPRESSIONS AND ADMINISTERED AMIODARONE AND EPINEPHRINE. THE AFIB PART OF THE PROCEDURE WAS ABORTED. THE PATIENT¿S LAST KNOW STATUS WAS STABLE. THE DEVICES USED DURING THE PROCEDURE WERE NGEN GENERATOR, CARTO 3 SYSTEM, 8MM CATHETER, LASSO NAV CATHETER, AND STERILMED REPROCESSED ACUNAV ULTRASOUND CATHETER. THE INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS THAT A BUBBLE WAS INTRODUCED WHILE GOING BACK UP WITH THE CATHETER THAT THEN ENTERED ONE OF THE CORONARY ARTERIES. THE INTERVENTION PROVIDED CONSISTED OF MEDICATION, CHEST COMPRESSION, AND DEFIBRILLATION. THE OUTCOME OF THE ADVERSE EVENT WAS THAT THE PATIENT FULLY RECOVERED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF OBSERVATION. THE ADVERSE EVENT WAS ASSESSED AS MDR REPORTABLE UNDER THE LASSO NAV CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504156 LASSO NAV CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Hospitalization| L CARTO 3 SYSTEM| UNK_NGEN RF GENERATOR