BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VARIPULSE¿ BI-DIRECTIONAL CATHETER

    MDR report key: 24021297 · Received January 9, 2026

    Report

    Report Number
    2029046-2026-00088
    Event Type
    Injury
    Date Received
    January 9, 2026
    Date of Event
    December 11, 2025
    Report Date
    January 23, 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
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CLARIFICATION RECEIVED ON 20-JAN-2026 INDICATED THAT THE ABNORMALITIES OBSERVED PRIOR TO USE OF THE PRODUCT USE WAS RELATED TO ST ELEVATION AND NOT ASSOCIATED WITH DEFICIENCIES OBSERVED PRIOR TO THE PRODUCT/VARIPULSE¿ BI-DIRECTIONAL CATHETER USE. THE ABNORMALITIES OBSERVED DURING USE OF THE PRODUCT WAS REGARDING THE ST ELEVATION AND NOT ASSOCIATED WITH DEFICIENCIES OBSERVED DURING USE OF THE PRODUCT/VARIPULSE¿ BI-DIRECTIONAL CATHETER. 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 14-JAN-2026, NOTED A CORRECTION TO THE 3500A INITIAL AS SHOULD HAVE PROCESSED THE FOLLOWING FIELDS AS FOLLOWS: -H7. REMEDIAL ACTION INITIATED TYPE = NOTIFICATION. -H9. FDA CORRECTION/ REMOVAL REPORTING NO. = 3013300026-01/17/2025-001-C. THE INVESTIGATION WAS COMPLETED ON 16-JAN-2026. IT WAS REPORTED THAT AFTER THE PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VARIPULSE¿ BI-DIRECTIONAL CATHETER, THE PATIENT EXPERIENCED AN ST ELEVATION TREATED WITH PERCUTANEOUS CORONARY INTERVENTION OF THE PERIPHERAL CORONARY ARTERY WAS PERFORMED. ADDITIONALLY, MILD CEREBRAL INFARCTION WAS OBSERVED. THE INFORMATION RECEIVED INDICATED THAT ST ELEVATION OCCURRED DURING THE PROCEDURE AND AN ABNORMALITY IN THE PATIENT'S RESPONSIVENESS WAS AFTER THE PROCEDURE. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE NUMBER LOT 31707014L AND NO INTERNAL ACTIONS RELATED TO THE COMPLAINT WERE FOUND DURING THE REVIEW. AN INTERNAL CORRECTIVE ACTION HAS BEEN OPENED 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 IS RECEIVED AT A LATER DATE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    INVESTIGATION IS IN PROGRESS, ONCE COMPLETED A SUPPLEMENTAL WILL BE SUBMITTED. 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 AFTER THE PATIENT UNDERWENT A CARDIAC ABLATION PROCEDURE WITH A VARIPULSE¿ BI-DIRECTIONAL CATHETER, THE PATIENT EXPERIENCED AN ST ELEVATION TREATED WITH PERCUTANEOUS CORONARY INTERVENTION OF THE PERIPHERAL CORONARY ARTERY WAS PERFORMED. ADDITIONALLY, MILD CEREBRAL INFARCTION WAS OBSERVED. THE INFORMATION RECEIVED INDICATED THAT ST ELEVATION OCCURRED DURING THE PROCEDURE AND AN ABNORMALITY IN THE PATIENT'S RESPONSIVENESS WAS AFTER THE PROCEDURE. THE PATIENT IS WELL WITH NO SEQUELAE. THE REPORT INDICATED THAT THE PATIENT EXPERIENCED ST ELEVATION AFTER THE PROCEDURE WITH A VARIPULSE¿ BI-DIRECTIONAL CATHETER. PERCUTANEOUS CORONARY INTERVENTION OF THE PERIPHERAL CORONARY ARTERY WAS PERFORMED, AND MILD CEREBRAL INFARCTION WAS OBSERVED. ADDITIONAL INFORMATION WAS RECEIVED ON 14-DEC-2025. THE ST ELEVATION OCCURRED DURING THE PROCEDURE AND AN ABNORMALITY IN THE PATIENT'S RESPONSIVENESS WAS AFTER THE PROCEDURE. THE PATIENT IS WELL WITH NO SEQUELAE. THE PHYSICIAN¿S ASSESSMENT OF THE HEALTH HAZARD WAS NOT SERIOUS (MODERATE/MILD). NO EXTENSION OF HOSPITALIZATION. THE PHYSICIAN¿S COMMENT ON THE RELATIONSHIP BETWEEN THE EVENT AND THE PRODUCT WAS THAT BECAUSE THE ST ELEVATION OCCURRED BEFORE THE ABLATION WITH VARIPULSE¿ BI-DIRECTIONAL CATHETER, IT MAY NOT BE RELATED TO THE ABLATION WITH VARIPULSE¿ BI-DIRECTIONAL CATHETER. ABNORMALITIES WERE OBSERVED PRIOR/DURING USE OF THE PRODUCT. DETAILS OF CLINICAL TESTS AND RESULTS INDICATED THAT THERE IS HIGH LIKELIHOOD OF CEREBRAL INFARCTION DUE TO THROMBUS. THE MEDICAL HISTORY / TREATMENT HISTORY / OTHER DISEASES CURRENTLY UNDER TREATMENT ARE PULMONARY EMBOLISM, DEEP VEIN THROMBOSIS OF THE LOWER EXTREMITIES, PROCEDURE PERFORMED USING ARGATROBAN BECAUSE OF HEPARIN INDUCED THROMBOCYTOPENIA (HIT). ADDITIONAL INFORMATION WAS RECEIVED ON 15-DEC-2025. THE CASE INVOLVED A PATIENT WITH PAF WHO UNDERWENT 18 ABLATIONS. THE ACT WAS MAINTAINED ABOVE 400 SECONDS THROUGHOUT THE PROCEDURE. POST-PROCEDURE, THE PATIENT DEVELOPED ST ELEVATION, UNDERWENT PCI FOR A DISTAL CORONARY LESION, AND WAS LATER CONFIRMED TO HAVE A MILD STROKE. INTERESTINGLY, THE ST ELEVATION PEAKED ABOUT THREE MINUTES AFTER THE TRANSSEPTAL PUNCTURE AND BEFORE THE PVI. BASED ON THIS, THE PHYSICIAN BELIEVES VARIPULSE¿ BI-DIRECTIONAL CATHETER MAY NOT HAVE BEEN A FACTOR. HOWEVER, THE PHYSICIAN REQUESTED INFORMATION ON ANY PRIOR EXPERIENCE USING VARIPULSE¿ BI-DIRECTIONAL CATHETER IN HIT PATIENTS AND WHETHER THERE HAVE BEEN STROKE EVENTS IN SUCH CASES. ADDITIONAL INFORMATION WAS RECEIVED ON 16-DEC-2025. THE OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED (NO RESIDUAL EFFECTS). THE ENERGY USED WAS PFA. THE CATHETERS EXCHANGED WAS ONE CATHETER WAS USED FOR EACH. THE TYPE OF NEUROLOGICAL ISSUE OBSERVED WAS SYMPTOMATIC. THE PATIENT¿S SYMPTOMS ARE RESOLVED. THE PATIENT DOES NOT HAVE A PREVIOUS HISTORY OF STROKE. NO OBSERVATIONS SUCH AS INTRACARDIAC EXCESSIVE MICROBUBBLES OBSERVED VIA ULTRASOUND, EXCESSIVE IMPEDANCE ERRORS NOTED DURING THE CASE. ADDITIONAL INFORMATION WAS RECEIVED ON 22-DEC-2025 WHICH INDICATES THAT AFTER THE PROCEDURE, THE MILD CEREBRAL INFARCTION WAS OBSERVED. ADDITIONAL INFORMATION WAS RECEIVED ON 29-DEC-2025. THE OUTCOME OF THE ADVERSE EVENT WAS FULLY RECOVERED (NO RESIDUAL EFFECTS). THE PATIENT DID NOT REQUIRE EXTENDED HOSPITALIZATION. THE PATIENT HAS BEEN DISCHARGED FROM THE HOSPITAL ON 16-DEC-2025. THE TYPE OF DELIVERED ENERGY WAS PFA. THE NEUROLOGICAL ISSUE OBSERVED WAS SYMPTOMATIC, AND THE PATIENT¿S SYMPTOMS WERE RESOLVED. NO EVIDENCE OF CHAR DURING THE PROCEDURE. THE PATIENT DID NOT HAVE A PREVIOUS HISTORY OF STROKE. PROCEDURAL ACT BEFORE THE PROCEDURE WAS 400 SECONDS OVER, AND THE PROCEDURAL ACT DURING THE PROCEDURE WAS 400 SECONDS OVER. ONE TRANSSEPTAL PUNCTURE SITE WAS PERFORMED DURING THE PROCEDURE. THE NUMBER OF PERFORMED ABLATIONS WAS 18 ABLATIONS WITH PFA ENERGY WITHIN THE PULMONARY VEINS. NO ABLATIONS WERE PERFORMED OUTSIDE THE PULMONARY VEINS. THE ACT WAS MAINTAINED ABOVE 400 SECONDS THROUGHOUT THE PROCEDURE. THE PATIENT HAD A HISTORY OF PULMONARY EMBOLISM, LOWER EXTREMITY DVT, AND (HIT) HEPARIN INDUCED THROMBOCYTOPENIA, SO THE PROCEDURE WAS PERFORMED USING ARGATROBAN. THE PHYSICIAN NOTICED THE ST ELEVATION AFTER THE PROCEDURE, BUT WHEN THEY REVIEWED THE RECORDING SYSTEM THE DAY AFTER THE PROCEDURE, THE PHYSICIAN CONFIRMED THAT THE ST ELEVATION HAD OCCURRED BEFORE ABLATION WITH VARIPULSE¿ BI-DIRECTIONAL CATHETER. THE ST ELEVATION OCCURRED AFTER COMPLETION OF THE TRANSSEPTAL PUNCTURE. AT THAT TIME THE VARIPULSE¿ BI-DIRECTIONAL CATHETER WAS INSIDE THE CARDIAC CHAMBER, BUT NO ABLATION HAD BEEN PERFORMED. ADDITIONAL INFORMATION RECEIVED ON 06-JAN-2025 INDICATED THAT THE PATIENT HAD HEPARIN INDUCED THROMBOCYTOPENIA (HIT) WHICH MAY BE A CAUSATIVE FACTOR IN THIS ADVERSE EVENT. ADDITIONAL INFORMATION WAS RECEIVED ON 08-JAN-2026. ALTHOUGH THE PHYSICIAN NOTICED ST ELEVATION AFTER THE PROCEDURE WAS COMPLETED, THE PHYSICIAN REVIEWED THE RECORD ON THE DAY AFTER THE PROCEDURE AND THE ECG LAB RECORD SHOWED ST ELEVATION BEFORE ABLATION WITH VARIPULSE¿ BI-DIRECTIONAL CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84337 VARIPULSE¿ BI-DIRECTIONAL CATHETER PERCUTANEOUS CARDIAC ABL CATH FOR TREATMT OF AFIB W IRREVERSIBLE ELECTROPORATION QZI BIOSENSE WEBSTER INC 31707014L 10846835025460

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Life Threatening| R NGEN PUMP, JAPAN CONFIGURATION.| TRUPULSE GENERATOR, JAPAN.| UNK RECORDING SYSTEM.