BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIPULSE¿ BI-DIRECTIONAL CATHETER

    MDR report key: 24273942 · Received February 5, 2026

    Report

    Report Number
    2029046-2026-00392
    Event Type
    Injury
    Date Received
    February 5, 2026
    Date of Event
    January 5, 2026
    Report Date
    February 5, 2026
    Manufacturer
    BIOSENSE WEBSTER INC
    Product Code
    QZI
    UDI-DI
    10846835025460
    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 HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY 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. IT WAS CONFIRMED THAT A TOTAL OF 40 PULSED FIELD (PF) ABLATIONS WERE PERFORMED FOR THE PROCEDURE. AN INCREASED NUMBER OF ABLATIONS (ENERGY APPLICATIONS) DELIVERED DURING THE PROCEDURE MAY BE LINKED TO THE HIGHER-THAN-ANTICIPATED INCIDENCE OF PERI-PROCEDURAL STROKE OR TIA. IN 90% OF THE CASES OF STROKE OR TIA REPORTED TO BWI WORLD-WIDE, PATIENTS RECEIVED A NUMBER OF ABLATIONS GREATER THAN THE MEDIAN NUMBER OF ABLATIONS DELIVERED IN THE INSPIRE STUDY (16 ABLATIONS) AND 60% RECEIVED A NUMBER OF ABLATIONS GREATER THAN THE MEDIAN NUMBER OF ABLATIONS DELIVERED IN THE ADMIRE STUDY (23 ABLATION). MOREOVER, PATIENTS RECEIVED MORE THAN 28 ABLATIONS IN 50% OF THE CASES OF STROKE OR TIA. IT WAS CONFIRMED THAT ABLATION WAS PERFORMED OUTSIDE PULMONARY VEINS. THE USE OF THE VARIPULSE¿ ABLATION CATHETER FOR ABLATIONS BEYOND PULMONARY VEIN ISOLATION MAY BE LINKED TO THE HIGHER-THAN-ANTICIPATED INCIDENCE OF PERI-PROCEDURAL STROKE OR TIA. IN 70% OF THE CASES OF STROKE OR TIA REPORTED TO BWI WORLD-WIDE, PATIENTS RECEIVED ABLATIONS OUTSIDE THE PULMONARY VEINS. THE SAFETY AND EFFECTIVE USE OF THIS DEVICE OUTSIDE OF THE PULMONARY VEINS FOR THE TREATMENT OF ATRIAL FIBRILLATION HAS NOT BEEN CLINICALLY ESTABLISHED AND MAY INCREASE THE RISK OF PATIENT INJURY. AN INTERNAL CORRECTIVE 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 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

    IT WAS REPORTED THAT ONE HALF TO TWO HOURS AFTER ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE WITH A VARIPULSE¿ BI-DIRECTIONAL CATHETER, THE PATIENT EXPERIENCED A STROKE WHICH REQUIRED EXTENDED HOSPITALIZATION. THE REPORT INDICATED THAT DURING AN AFIB PULSED FIELD ABLATION (PFA) CASE WITH THE VARIPULSE CATHETER, THE CASE COMPLETED WITHOUT ANY ISSUE. THE PATIENT WAS FINE, RESPONSIVE, TALKING AND MOVING AFTER THE PROCEDURE. THEN, THE LAB MANAGER INDICATED THAT ONE AND ONE HALF TO TWO HOURS AFTER THE CASE WAS COMPLETED, DURING THE POST ANESTHESIA RECOVERY PERIOD, THE PATIENT WAS FOUND UNRESPONSIVE AND WITH FIXED PUPILS. ALL ORIGINAL TESTS CAME BACK NEGATIVE OR INCONCLUSIVE FOR STROKE, COMPUTED TOMOGRAPHY (CT) SCANS, GASES, AND ALL WERE CHECKED. THE PATIENT HAD A MAGNETIC RESONANCE IMAGING (MRI) TEST THAT SHOWED POSSIBLE INFARCTION, AND NOTIFICATION WAS RECEIVED AT THE TIME OF REPORTING WHICH RULED IT A STROKE. THE PULMONARY VEIN ISOLATION (PVI) AND POSTERIOR WALL ABLATION WAS COMPLETED DURING THE CASE WITH A TOTAL NUMBER OF PFA APPLICATIONS OF 40 ABLATIONS. DURING THE CASE, THE PHYSICIAN WAS NOTIFIED THAT THEY WERE INCHING CLOSE OR REACHING THE UPPER LIMIT OF THE RECOMMENDED WORKFLOW FOR ABLATION, BUT THE PHYSICIAN USUALLY DOES OVER ABLATE. STATUS OF THE PATIENT IS INTUBATED AND UNRESPONSIVE. THE PRODUCTS USED WERE AS FOLLOWS: OCTARAY CATHETER (LOT: 31623409L CAT: D160906), DECANAV CATHETER (LOT: UNKNOWN CAT: R7F282CT), VIZIGO SHEATH (CAT: D138502, LOT: 71054108), VIZIGO SHEATH (CAT: D138502 , LOT 60000721 ), VARIPULSE CATHETER (CAT: D141201 - LOT: UNKNOWN), CARTO 3 SYSTEM (34223), AND TRUPULSE GENERATOR (SN: (B)(6). ADDITIONAL INFORMATION WAS RECEIVED WHICH INDICATED THAT THE PHYSICIAN¿S OPINION ON THE CAUSE OF THIS ADVERSE EVENT WAS UNKNOWN. THE PHYSICIAN NOTED POSSIBLE INFECTION PRIOR TO THE CASE, BUT THIS WAS SPECULATION. OTHERWISE, THE PHYSICIAN DID NOT PLACE ANY BLAME ON ANY BIOSENSE WEBSTER INC. (BWI) PRODUCT. THE INTERVENTION PROVIDED WAS GENERAL ANESTHESIA AND INTUBATION. THE OUTCOME OF THE ADVERSE EVENT, AS OF ON (B)(6) 2026, HAS IMPROVED AND HAS BEEN EXTUBATED. THE PATIENT REQUIRED EXTENDED HOSPITALIZATION BECAUSE OF INTUBATION AND FURTHER TESTING. THE ONLY PREOPERATIVE TESTING NOTED ON THE PATIENT¿S CHART WAS PT OF 13.1 AND AN INR OF 1.2 AS OF ON (B)(6) 2025. NO LAB WORK WAS AVAILABLE FOR THE DAY OF THE PROCEDURE. THE POST PROCEDURAL MRI SHOWED AN ANOMALOUS ARTERY OF PERCHERON. THE ACTIVATED CLOTTING TIME (ACT) BEFORE THE PROCEDURE/ABLATION WAS 389. THE ACT DURING PROCEDURE WERE 389, 337, AND 358. THE SHEATH AND THE CATHETER WERE EXCHANGED TWICE. ONE TRANSSEPTAL PUNCTURE SITE WAS PERFORMED DURING THE PROCEDURE. ALL ABLATIONS WERE CONDUCTED WITH PFA ENERGY. THERE WERE TWENTY-FOUR ABLATIONS PERFORMED WITHIN THE PULMONARY VEINS, WITH SIXTEEN OUT OF VEIN ABLATIONS (FOURTEEN POSTERIOR WALL, TWO SUPERIOR VENA CAVA) OUT OF THE PULMONARY VEINS. OTHER PROCEDURAL NOTES INDICATED THAT THE PATIENT PRESENTED IN AFIB DURING MAPPING AND CARDIOVERTED AT 360 JOULES. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS NOT PERFORMED, BUT THE PHYSICIAN CLEARED THE APPENDAGE WITH INTRACARDIAC ECHOCARDIOGRAPHY (ICE) PRIOR TO TRANSSEPTAL. AFTER COMPLICATION WAS PRESENTED, CT SCANS, BLOOD GASES AND LAB WORK WERE ALL NEGATIVE/NORMAL. THE PATIENT WAS TAKEN FOR AN MRI THE NEXT DAY (TUESDAY, ON (B)(6) 2026) WHICH SHOWED BRAIN STEM INFARCT. THE NEUROLOGICAL ISSUE OBSERVED WAS SYMPTOMATIC (RESPIRATORY FAILURE, FIXED PUPILS, AND NON-RESPONSIVENESS). NO EVIDENCE OF CHAR NOR BLOOD THROMBUS/CLOT DURING THE PROCEDURE. NO PREVIOUS HISTORY OF STROKES. THE IRRIGATION RATE USED DURING THIS PROCEDURE WAS 30ML/MIN. UNFORTUNATELY, THE BOX/PACKAGING IS UNAVAILABLE TO OBTAIN THE LOT NUMBERS. AS THE EVENT OCCURRED TWO HOURS AFTER THE PROCEDURE ENDED, ALL MATERIALS WERE THROWN AWAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331791 VARIPULSE¿ BI-DIRECTIONAL CATHETER PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION QZI BIOSENSE WEBSTER INC 10846835025460

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R| L 7FR DECAN,11P, F,2.4MMLE,282MM.| 8.5F SHEATH WITH CURVE VIZ MDC.| 8.5F SHEATH WITH CURVE VIZ MDC.| CARTO 3 SYSTEM.| OCTA, LNG,48P,3-3-3-3-3, F-CURVE.| TRUPULSE GENERATOR, US.