BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIPULSE¿ BI-DIRECTIONAL CATHETER

    MDR report key: 22959930 · Received September 3, 2025

    Report

    Report Number
    2029046-2025-02985
    Event Type
    Injury
    Date Received
    September 3, 2025
    Date of Event
    August 7, 2025
    Report Date
    November 3, 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
    NO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 07-SEP-2025 WHICH INDICATED THAT THE ERROR MESSAGE OF "HIGH VOLTAGE DETECTED ON NON-ACTIVE ELECTRODE" WAS REPORTED. THIS ERROR MESSAGE WAS ASSESSED AS NON MDR REPORTABLE AS A RECURRENCE OF THE MALFUNCTION IS UNLIKELY TO CONTRIBUTE TO A DEATH OR NEED FOR MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE SERIOUS INJURY (PERMANENT IMPAIRMENT TO A BODY FUNCTION, PERMANENT DAMAGE TO A BODY STRUCTURE). THEREFORE, ADDED UNDER H6. MEDICAL DEVICE PROBLEM CODE "HIGH READINGS (A090807)". IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    Additional Manufacturer Narrative · 0

    DURING AN INTERNAL REVIEW ON 09-OCT-2025, A CORRECTION WAS NOTED TO THE 3500A INITIAL UNDER THE FOLLOWING CODING AND THEREFORE, REMOVED: H6. INVESTIGATION FINDINGS: USAGE PROBLEM IDENTIFIED (C23). H6. INVESTIGATION CONCLUSIONS: CAUSE TRACED TO USER (D11). IF ADDITIONAL INFORMATION IS RECEIVED REGARDING THIS EVENT, A SUPPLEMENTAL 3500A REPORT WILL BE SUBMITTED TO THE FDA. MANUFACTURER'S REFERENCE NUMBER: (B)(4).

    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. THE INVESTIGATION WAS COMPLETED ON 29-AUG-2025. 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 PATIENT WAS TREATED FOR PERSISTENT AFIB (PSAF). THE SAFETY AND EFFICACY OF THE VARIPULSE¿ CATHETER WHEN USED WITH A TRUPULSE¿ GENERATOR HAS BEEN DETERMINED IN THE ADMIRE AND INSPIRE TRIALS IN THE TREATMENT OF SUBJECTS WITH SYMPTOMATIC PAROXYSMAL ATRIAL FIBRILLATION (PAF). THE SAFETY AND EFFICACY OF THEIR USE IN THE TREATMENT OF OTHER ARRHYTHMIAS HAVE NOT BEEN ESTABLISHED. IT WAS CONFIRMED THAT A TOTAL OF 29 PF ABLATIONS (8 OF THEM INCOMPLETE, 73 APPLICATIONS IN TOTAL) 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. 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 INSTRUCTIONS FOR USE (IFU) ARE INSTRUCTIONS THAT PROVIDE DETAILED GUIDANCE ON HOW SAFELY AND EFFECTIVELY TO 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. HOWEVER, IF THE PRODUCT OR PRODUCT ID NUMBERS ARE RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. MANUFACTURER¿S REFERENCE NUMBER: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ATRIAL FIBRILLATION (AFIB) CARDIAC ABLATION PROCEDURE WITH A VARIPULSE¿ BI-DIRECTIONAL CATHETER, THE PATIENT EXPERIENCED A CEREBROVASCULAR ACCIDENT AND REQUIRED EXTENDED HOSPITALIZATION. THE PATIENT SUSTAINED A CEREBRAL MICROINFARCTION AFTER PFA USING A VARIPULSE¿ BI-DIRECTIONAL CATHETER. THE RELATIONSHIP BETWEEN THE ADVERSE EVENT AND THE CATHETER IS NOT KNOWN. THE PATIENT DID NOT REQUIRE REVISION SURGERY AND AN MRI WAS COMPLETE. ADDITIONAL INFORMATION WAS RECEIVED. THE PHYSICIAN'S OPINION ON THE CAUSE OF THE ADVERSE EVENT IS STILL UNDER INVESTIGATION. ONLY 1 CATHETER EXCHANGE OCCURRED. ONLY ONE TRANSSEPTAL PUNCTURE WAS PERFORMED. 29 ABLATIONS WERE PERFORMED, 8 OF THEM WERE INCOMPLETE, 73 APPLICATIONS IN TOTAL. ALL ABLATIONS WERE PERFORMED IN THE PULMONARY VEIN OR ANTRUM OF THE PULMONARY VEIN. THERE WAS NO EVIDENCE OF CHAR / THROMBUS / CLOT DURING THE PROCEDURE. NO EXCESSIVE MICROBUBBLES OR EXCESSIVE IMPEDANCE ERRORS NOTED DURING THE CASE. NO STACKING OCCURRED FOR THIS PROCEDURE. THE IRRIGATION RATE USED WAS 4 ML/MIN. THE PATIENT'S RHYTHM DURING ABLATION WAS ATRIAL FIBRILLATION. THE PROCEDURE WAS FOR PERSISTENT ATRIAL FIBRILLATION. THE CORRECT CATHETER SETTINGS WERE SELECTED ON THE GENERATOR. NO ISSUES WITH FLOW RATE CHANGE AT THE START OF ABLATION. THE TYPE OF ELECTROPHYSIOLOGY PROCEDURE BEING PERFORMED WAS A NEW PROCEDURE. IT WAS REPORTED THAT THE PATIENT HAD A SYMPTOMATIC CEREBROVASCULAR ACCIDENT. THE PATIENT'S SYMPTOMS DID RESOLVE. IT WAS REPORTED THAT THE PATIENT IMPROVED; HOWEVER, REQUIRED EXTENDED HOSPITALIZATION AND DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2449096 VARIPULSE¿ BI-DIRECTIONAL CATHETER PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION QZI BIOSENSE WEBSTER INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| L NGEN PUMP, EU CONFIGURATION| UNK_TRUPULSE GENERATOR