BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_VARIPULSE

    MDR report key: 23693989 · Received December 2, 2025

    Report

    Report Number
    2029046-2025-03968
    Event Type
    Injury
    Date Received
    December 2, 2025
    Date of Event
    October 13, 2025
    Report Date
    December 2, 2025
    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
    GM
    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 CITE HAS BEEN REVIEWED: SCHREIBER T, RENNENBERG RV, BRÄMSWIG TB, LANDMESSER U, HINDRICKS G, NAGEL P, TSCHOLL V, HUEMER M, LUCAS J, ATTANASIO P, NOLTE CH. COMPARISON OF CEREBRAL MICRO-EMBOLIZATION DETECTED BY TRANSCRANIAL DOPPLER EXAMINATION BETWEEN RADIOFREQUENCY ABLATION AND PULSED FIELD ABLATION FOR ATRIAL FIBRILLATION. J CARDIOVASC ELECTROPHYSIOL. 2025 OCT 13. DOI: 10.1111/JCE.70140. EPUB AHEAD OF PRINT. PMID: 41078013. 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. AN INTERNAL ACTION IS BEING FOLLOWED TO INVESTIGATE NEUROVASCULAR EVENTS WITH VARIPULSE CATHETERS. IMPORTANTLY, THE MECHANISM FOR AN INCIDENCE OF STROKE IS MULTI-FACTORIAL. THE INVESTIGATION ALSO CONCLUDED THAT THE RISK OF NEUROVASCULAR EVENTS MAY INCREASE IF A HIGH NUMBER OF ABLATIONS, STACKING OF ABLATIONS AND/OR ABLATION OUTSIDE OF THE PULMONARY VEINS ARE DELIVERED. THE IFUS (INSTRUCTIONS FOR USE) ARE INSTRUCTIONS THAT PROVIDE DETAILED GUIDANCE ON HOW SAFELY AND EFFECTIVELY USE A MEDICAL DEVICE. IT IS THE PHYSICIAN¿S RESPONSIBILITY TO REVIEW THE PATIENT¿S MEDICAL HISTORY AND MAKE THE BEST-INFORMED DECISION BASED ON ALL AVAILABLE INFORMATION. AS PART OF OUR COMPANY QUALITY SYSTEM PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND DISTRIBUTED 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

    THIS COMPLAINT IS FROM A LITERATURE SOURCE. THE FOLLOWING LITERATURE CITE HAS BEEN REVIEWED: SCHREIBER T, RENNENBERG RV, BRÄMSWIG TB, LANDMESSER U, HINDRICKS G, NAGEL P, TSCHOLL V, HUEMER M, LUCAS J, ATTANASIO P, NOLTE CH. COMPARISON OF CEREBRAL MICRO-EMBOLIZATION DETECTED BY TRANSCRANIAL DOPPLER EXAMINATION BETWEEN RADIOFREQUENCY ABLATION AND PULSED FIELD ABLATION FOR ATRIAL FIBRILLATION. J CARDIOVASC ELECTROPHYSIOL. 2025 OCT 13. DOI: 10.1111/JCE.70140. EPUB AHEAD OF PRINT. PMID: 41078013. BACKGROUND: PULSED FIELD ABLATION (PFA) CAN ESTABLISH PULMONARY VEIN ISOLATION VIA IRREVERSIBLE ELECTROPORATION AND IS BELIEVED TO REDUCE OVERALL COMPLICATIONS; HOWEVER, PERIPROCEDURAL STROKE HAS ALSO BEEN REPORTED AFTER PFA PROCEDURES. ASSESSMENT OF MICROEMBOLIC SIGNALS (MES) MEASURED BY TRANSCRANIAL DOPPLER (TCD) ALLOWS TO MONITOR CEREBRAL EMBOLIZATION DURING THE PROCEDURE AND TO IDENTIFY HIGHER RISK PROCEDURAL STEPS. OBJECTIVE: THIS STUDY WAS DESIGNED TO COMPARE THE INCIDENCE OF MES DURING DIFFERENT PROCEDURAL STEPS BETWEEN TWO DIFFERENT PFA SYSTEMS AND RADIOFREQUENCY ABLATION (RFA). METHODS: PULMONARY VEIN ISOLATION WAS PERFORMED EITHER USING EITHER HIGH-POWER SHORT-DURATION RADIOFREQUENCY ABLATION (HPSD RFA), OR PFA USING A VARIABLE LOOP CIRCULAR CATHETER (VLCC) OR A CIRCULAR MULTIELECTRODE ARRAY CATHETER (CMAC). MES WERE COMPARED DURING TRANSSEPTAL PUNCTURE, ABLATION, LEFT ATRIAL MAPPING, AND INTRODUCTION/RETRACTION OF CATHETERS. NEUROLOGICAL EXAMINATION WAS PERFORMED PRE AND POST ABLATION FOR ALL PATIENTS INCLUDING THE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS). CONCLUSIONS: PULSED FIELD ABLATION WAS ASSOCIATED WITH A HIGHER CEREBRAL MES COUNT THAN HIGH-POWER SHORT-DURATION RADIOFREQUENCY ABLATION, WITH MARKED DIFFERENCES BETWEEN CATHETER SYSTEMS. TRANSCRANIAL DOPPLER INDICATES ABLATION AS THE MOST EMBOLIC STEP IN BOTH PFA AND HIGH-POWER SHORT DURATION ABLATION. LOT, MODEL, AND CATALOG NUMBER ARE NOT AVAILABLE, BUT THE SUSPECTED BWI DEVICE IS POSSIBLY ASSOCIATED WITH REPORTED ADVERSE EVENTS: USING A THERMOCOOL SMARTTOUCH SF CATHETER (BIOSENSE WEBSTER INC). OTHER BWI PRODUCTS: ELECTROANATOMICAL MAPPING (CARTO 3, BIOSENSE WEBSTER INC); PENTASPLINE CATHETER (PENTARAY, BIOSENSE WEBSTER INC); VARIPULSE¿ VARIABLE- LOOP CIRCULAR CATHETER (VLCC; BIOSENSE WEBSTER INC.; IRVINE, CA) NON-BWI DEVICES: 8.5 FRENCH AGILIS SHEATH (ABBOTT, CHICAGO, IL, USA); 10 FRENCH SHEATH (FLEXCATH CONTOUR¿, MEDTRONIC, DUBLIN, IRELAND); PULSESELECT SYSTEM (MEDTRONIC, MINNEAPOLIS, MN, USA) ADVERSE EVENT(S) AND PROVIDED INTERVENTIONS FOR BWI DEVICES: QTY 131 : MICROEMBOLIC SIGNALS (MES). NO INTERVENTION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1912455 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 SYSTEM| PENTARY