BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_VARIPULSE

    MDR report key: 24040318 · Received January 12, 2026

    Report

    Report Number
    2029046-2026-00109
    Event Type
    Injury
    Date Received
    January 12, 2026
    Date of Event
    October 31, 2025
    Report Date
    January 12, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    QZI
    PMA / PMN Number
    P240006
    Removal / Correction Number
    3013300026-01/17/2025-00
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE ARTICLE HAS BEEN REVIEWED: DI BIASE L, REDDY VY, ZHANG X, NEWTON D, GOYAL S, NAIR D, SAUER WH, IYER V, LIU CF, OSORIO J, MANSOUR M, CALKINS H, WAZNI O, NATALE A. PROCEDURAL CHARACTERISTICS AND CLINICAL OUTCOMES FROM SAME-DAY DISCHARGE AFTER PULSED FIELD ABLATION TREATMENT FOR ATRIAL FIBRILLATION: AN ADMIRE TRIAL SUB-ANALYSIS. EUROPACE. 2025 OCT 31;27(11):EUAF270. DOI: 10.1093/EUROPACE/EUAF270. PMID: 41239566; PMCID: PMC12618193. NO DEVICE WAS RECEIVED FOR ANALYSIS AT THE TIME OF SUBMISSION OF THE INITIAL 3500A. SINCE THE PRODUCT WAS NOT RETURNED FOR ANALYSIS, NO PRODUCT FAILURE ANALYSIS CAN BE CONDUCTED, AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. DEVICE HISTORY RECORD (DHR) REVIEW CANNOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS PROVIDED BY THE CUSTOMER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 4. 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE ARTICLE HAS BEEN REVIEWED: DI BIASE L, REDDY VY, ZHANG X, NEWTON D, GOYAL S, NAIR D, SAUER WH, IYER V, LIU CF, OSORIO J, MANSOUR M, CALKINS H, WAZNI O, NATALE A. PROCEDURAL CHARACTERISTICS AND CLINICAL OUTCOMES FROM SAME-DAY DISCHARGE AFTER PULSED FIELD ABLATION TREATMENT FOR ATRIAL FIBRILLATION: AN ADMIRE TRIAL SUB-ANALYSIS. EUROPACE. 2025 OCT 31;27(11):EUAF270. DOI: 10.1093/EUROPACE/EUAF270. PMID: 41239566; PMCID: PMC12618193. BACKGROUND: PULMONARY VEIN ISOLATION SERVES AS THE STANDARD CATHETER-BASED TREATMENT FOR ATRIAL FIBRILLATION (AF) AND IS PERFORMED USING VARIOUS ENERGY MODALITIES, INCLUDING RADIOFREQUENCY AND CRYOBALLOON ABLATION. RECENTLY, PULSED FIELD ABLATION (PFA) HAS EMERGED AS A NOVEL TECHNIQUE THAT OFFERS IMPROVED TISSUE SELECTIVITY AND A PROMISING SAFETY AND EFFICACY PROFILE THAT IS COMPARABLE WITH EARLIER ABLATION MODALITIES. THIS CONTEXT, AN INNOVATIVE INTEGRATED PFA SYSTEM, INCORPORATING NON- FLUOROSCOPIC GUIDANCE THROUGH ONLINE ELECTROANATOMICAL MAPPING AND TISSUE-TO-CATHETER PROXIMITY FEEDBACK, WAS DEVELOPED TO OPTIMISE PROCEDURAL SAFETY AND EFFICACY. INITIAL EVALUATION OF THIS INTEGRATED PFA SYSTEM OCCURRED THROUGH THE INSPIRE TRIAL (CLINICALTRIALS.GOV IDENTIFIER: NCT04524364), WHICH ASSESSED 12-MONTH POST-ABLATION CLINICAL OUTCOMES IN EUROPEAN AND CANADIAN PATIENTS. THIS STUDY WAS FOLLOWED BY THE US ADMIRE TRIAL (CLINICALTRIALS.GOV IDENTIFIER: NCT05293639), WHICH ENROLLED 277 PATIENTS WITH PAROXYSMAL AF (PAF) ACROSS 30 CENTRES, AND CONFIRMED THIS SYSTEM¿S SAFETY AND EFFECTIVENESS THROUGH DEMONSTRATED HIGH ACUTE EFFICACY (SHORT PROCEDURE DURATION), LOW COMPLICATION RATES, AND REDUCED FLUOROSCOPY EXPOSURE. SAME-DAY DISCHARGE (SDD) FOLLOWING AFABLATION HAS GAINED INTEREST AS A STRATEGY TO IMPROVE HEALTHCARE EFFICIENCY, REDUCE HOSPITAL COSTS AND PATIENT ABLATION WAIT TIMES, AND ENHANCE OVERALL PATIENT SATISFACTION. IT HAS BEEN INCREASINGLY UTILIZED IN THE ELECTROPHYSIOLOGY COMMUNITY LONG BEFORE THE ADVENT OF PFA. 12¿14 HISTORICALLY, PATIENTS UNDERGOING CATHETER ABLATION FOR AF HAVE BEEN OBSERVED OVERNIGHT DUE TO THE PROCEDURAL COMPLEXITY AND THE PERCEIVED RISK OF POST-PROCEDURAL COMPLICATIONS. HOWEVER, INCREASING EVIDENCE SUPPORTS THAT SDD IS BOTH SAFE AND FEASIBLE IN PATIENTS WHO UNDERGO AN EVALUATION OF KEY FACTORS, INCLUDING: (1) STABLE ANTICOAGULATION, (2) ABSENCE OF BLEEDING HISTORY, (3) NO SYSTOLIC HEART FAILURE, (4) NO HISTORY OF PULMONARY DISEASE, (5) NO RECENT CARDIAC INTERVENTIONS WITHIN 60 DAYS OF ABLATION, (6) BODY MASS INDEX (BMI) < 35 KG/M 2 =3). 15, AND (7) ACCEPTABLE CHA 2 DS 2-VASC STROKE RISK (TYPICALLY ADDITIONALLY, SDD IS MORE LIKELY TO BE IMPLEMENTED FOR PROCEDURES PERFORMED EARLIER IN THE DAY AND UNDER CONSCIOUS SEDATION. DESPITE THESE CONSIDERATIONS, THERE ARE LIMITED DATA EVALUATING SDD IN THE CONTEXT OF PFA, PARTICULARLY WITH NEWER INTEGRATED SYSTEMS. EXISTING STUDIES EXAMINING SDD IN CATHETER ABLATION ARE OFTEN OBSERVATIONAL, WHICH CAN INTRODUCE BIASES RELATED TO PATIENT AND SITE SELECTION. 16 FOR EXAMPLE, SOME STUDIES INDICATE THAT PROCEDURES FOR PARTICIPANTS AS SIGNED TO SDD WERE SHORTER, WERE MORE LIKELY TO BE REPEAT ABLATIONS, WERE GENERALLY PERFORMED UNDER SEDATION RATHER THAN GENERAL ANAESTHESIA, AND WERE LESS LIKELY TO INVOLVE LINEAR LESIONS OR ELECTRICAL CARDIOVERSION. CONSEQUENTLY, THE RESULTS MAY SHOW AN APPARENT ADVANTAGE IN PROCEDURAL SUCCESS AND THE SAFETY PROFILE FOR SDD, WHICH CAN COMPLICATE INTERPRETATION. CONVERSELY, LONG-TERM SAFETY AND EFFICACY OF SDD IS COMPARABLE WITH THAT OF OVERNIGHT STAYS (ONS) REGARDLESS OF THE ABLATION MODALITY EMPLOYED, WHETHER RADIOFREQUENCY OR BALLOON- BASED TECHNIQUES. 17 THIS AD HOC ANALYSIS OF THE ADMIRE TRIAL WAS CONDUCTED TO EVALUATE THE SAFETY AND EFFECTIVENESS OF SDD COMPARED WITH ONS FOLLOWING PFA PROCEDURES USING THE VARIABLE-LOOP CIRCULAR CATHETER (VLCC). BY ASSES SING REAL-WORLD PROCEDURAL AND CLINICAL OUTCOMES, THIS ANALYSIS AIMS TO INFORM BEST PRACTICES FOR POST-PROCEDURAL CARE IN THE ERA OF NEXT- GENERATION ABLATION TECHNOLOGIES. OBJECTIVES: SAME-DAY DISCHARGE (SDD) FOLLOWING CATHETER ABLATION FOR ATRIAL FIBRILLATION (AF) YIELDS A PROMISING APPROACH TO ENHANCE PATIENT SATISFACTION AND REDUCE HEALTHCARE COSTS. WHILE PRIOR DATA SUPPORT THE SAFETY OF SDD AFTER RADIOFREQUENCY ABLATION, EVIDENCE FOLLOWING PULSED FIELD ABLATION (PFA) REMAINS LIMITED. THIS SUB-ANALYSIS OF THE ADMIRE TRIAL (NCT05293639) EVALUATES THE SAFETY OF SDD COMPARED WITH OVERNIGHT STAYS (ONS) AFTER PFA USING A VARIABLE-LOOP CIRCULAR CATHETER (VLCC). METHODS: BASELINE AND PROCEDURAL CHARACTERISTICS, SAFETY, AND EFFECTIVENESS WERE COMPARED BETWEEN SDD AND ONS GROUPS. PRIMARY EFFECTIVENESS WAS DEFINED AS FREEDOM FROM COMPOSITE FAILURE USING KAPLAN¿MEIER ESTIMATES. SERIOUS ADVERSE EVENTS (SAES) OCCURRING =7 DAYS AND =1 DAY POST-INDEX PROCEDURE WERE ASSESSED. AMONGST 277 PATIENTS IN THE ADMIRE TRIAL, 119 (43.0%) COMPLETED SDD, AND 158 (57.0%) STAYED OVERNIGHT. THE SDD GROUP INCLUDED FEWER PATIENTS AGED =65 YEARS (41.2% VS. 52.5%), SHORTER FLUOROSCOPY TIMES (4.0 VS. 8.9 MIN), HIGHER FIRST-PASS ISOLATION RATES (97.5% VS. 82.9%), AND FEWER PROCEDURAL AES (1.7% VS. 3.8%). MORE PROCEDURES IN THE SDD GROUP OCCURRED IN THE MORNING (63.0% VS. 39.2%). FREEDOM FROM PRIMARY EFFECTIVENESS FAILURE WAS SIMILAR (SDD, 75.4% [95% CI 67.4¿83.3%] VS. ONS, 74.0% [95% CI 66.4¿81.5%]). NO SIGNIFICANT DIFFERENCE IN SAE RISK WAS OBSERVED OVERALL [HR, 1.07 (95% CI 0.47¿2.44)] OR =7 DAYS POST-PROCEDURE [HR, 0.78 (95% CI 0.17¿3.49)]. POST-PROCEDURAL SERIOUS CARDIAC/VASCULAR AE RATES WERE ALSO COMPARABLE (SDD, 2.5% VS. ONS, 1.3%). CONCLUSIONS: SDD IS FEASIBLE IN A PAROXYSMAL AF POPULATION UNDERGOING PFA WITH THE VLCC, DEMONSTRATING COMPARABLE SAFETY AND EFFECTIVENESS OUTCOMES WITH OVERNIGHT HOSPITALIZATION. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: VARIABLE-LOOP PFA CATHETER (VARIPULSE CATHETER, BIOSENSE WEBSTER, INC., PART OF JOHNSON & JOHNSON MEDTECH, IRVINE, CA, USA). OTHER BWI PRODUCTS: INTEGRATED ELECTROANATOMICAL MAPPING (EAM) SYSTEM (CARTO 3 SYSTEM, BIOSENSE WEBSTER, INC., PART OF JOHNSON & JOHNSON MEDTECH). NON-BWI DEVICES: KARDIAMOBILE 6L (MANUFACTURER NOT STATED). ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 3: 3 CASES OF CARDIAC TAMPONADE OR PERFORATION. NO INTERVENTION MENTIONED. QTY 1: 1 CASE OF PERICARDITIS. NO INTERVENTION MENTIONED. QTY 2: 2 CASES OF STROKE/CEREBROVASCULAR ACCIDENT. NO INTERVENTION MENTIONED. QTY 1: 1 CASE OF TRANSIENT ISCHEMIC ATTACK. NO INTERVENTION MENTIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95515 UNKNOWN_VARIPULSE PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION QZI BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening CARTO 3.| KARDIAMOBILE 6L.| UNKNOWN_VARIPULSE.