BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LASSO® NAV ECO VARIABLE CATHETER

    MDR report key: 18840804 · Received March 5, 2024

    Report

    Report Number
    2029046-2024-00732
    Event Type
    Injury
    Date Received
    March 5, 2024
    Date of Event
    February 8, 2024
    Report Date
    April 3, 2024
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    DRF
    UDI-DI
    10846835009637
    PMA / PMN Number
    K113213
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. 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

    AFTER AN INTERNAL REVIEW, THIS EVENT WAS REASSESSED AS NOT MDR REPORTABLE. CARDIOVERSION APPLIED DURING A CARDIAC ABLATION PROCEDURE IS NOT A MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. RATHER, IT IS A WELL-KNOWN AND COMMONLY ACCEPTED ALTERNATIVE PROCEDURAL STEP TO ACHIEVE SINUS RHYTHM. THERE WAS NO EXTENDED HOSPITALIZATION. AS SUCH, THE H 6. MEDICAL DEVICE PROBLEM CODE WAS UPDATED TO ¿APPROPRIATE TERM/CODE NOT AVAILABLE (A27)¿ WHICH REFERS TO ¿PATIENT EVENT - NON SERIOUS¿. SINCE THIS EVENT HAS ALREADY BEEN REPORTED TO FDA, BIOSENSE WEBSTER INC. WILL CONTINUE TO SUBMIT SUPPLEMENTAL MDRS TO FDA WITH ANY UPDATES EVEN THOUGH THIS EVENT IS NO LONGER CONSIDERED MDR REPORTABLE. THEREFORE, THE DEVICE EVALUATION DETAILS ARE BEING REPORTED. THE DEVICE WAS RETURNED TO BIOSENSE WEBSTER (BWI) FOR EVALUATION. A VISUAL INSPECTION, DEFLECTION, CONTRACTION, AND MAGNETIC SENSOR FUNCTIONALITY TEST OF THE RETURNED DEVICE WERE FOLLOWING BWI PROCEDURES. VISUAL ANALYSIS REVEALED NO DAMAGE OR ANOMALIES ON THE DEVICE. NO DEFLECTION ISSUES WERE OBSERVED. THE CONTRACTION MECHANISM WAS TESTED, AND THE LOOP WAS CONTRACTING WITHIN SPECIFICATIONS. NO ISSUES WERE OBSERVED. THE DEVICE WAS CONNECTED TO THE CARTO 3 SYSTEM, AND IT WAS RECOGNIZED; HOWEVER, ERROR 116 WAS DISPLAYED ON THE SCREEN TO AN INTERNAL EEPROM COMPONENT FAILURE. A DEFLECTION TEST WAS PERFORMED, AND THE CURVE WAS DEFLECTING WITHIN SPECIFICATIONS. THE ERROR 116 OBSERVED IS UNRELATED TO THE REPORTED EVENT. THE ISSUE REPORTED BY THE CUSTOMER WAS NOT CONFIRMED, HOWEVER A MAGNETIC ERROR WAS OBSERVED DURING THE PRODUCT INVESTIGATION. PRODUCT FAILURE IS MULTIFACTORIAL. AS PART OF BIOSENSE WEBSTER'S QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH BWI'S 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 A SUPRAVENTRICULAR TACHYCARDIA (SVT) CARDIAC ABLATION PROCEDURE WHICH INCLUDED THE USE OF A LASSO® NAV ECO VARIABLE CATHETER AND THE PATIENT EXPERIENCED ATRIAL FIBRILLATION (AFIB) TREATED WITH CARDIOVERSION. IT WAS REPORTED THAT WHEN INSERTING THE LASSONAV CATHETER, THE PATIENT WENT INTO AFIB. THE PHYSICIAN FEELS THAT THE ISSUE IS RELATED TO THE CATHETER FREQUENCIES ON THE CARTO 3 SYSTEM. PATIENT HAS FULLY RECOVERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137229 LASSO® NAV ECO VARIABLE CATHETER CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING DRF BIOSENSE WEBSTER INC 31130064L 10846835009637

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Male Required Intervention CARTO 3 SYSTEM| NGEN RF GENERATOR, US| QDOT MICRO, UNI, TC, F