MAUDE Adverse Event Report: Biosense Webster Inc VARIPULSE¿ Bi-Directional Catheter; Percutaneous Cardiac Abl Cath for Treatmt of AFib w Irreversible Electroporation

Catalog Number	D141201
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Ischemic Heart Disease (2493); Pericarditis (4448)
Date of Event	05/04/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent pulmonary vein isolation and cavotricuspid isthmus (cti) ablation and the patient experienced pericarditis.Three days after the case, patient experienced acute breathlessness, and sore while lying on back.The patient went to "nhs".No pericardial effusion on echo, but symptoms consistent with pericarditis.It was also reported that there was an indication that st change on electrocardiogram may be a vagal response.On review of the case details from the carto system, 37 radiofrequency (rf) lesions were delivered at the cti with the thermocool smarttouch sf catheter.Pulmonary vein isolation was performed with the varipulse¿ bi-directional catheter plus workflow - 4 ablations per vein/16 total, with 4ml/min passive irrigation and 30ml/min during pulsed field ablation (pfa) application.The physician indicated initially that he thought the potential pericarditis could have been a result of pfa, although once he saw the number of rf lesions, he determined the cti ablations would be a more likely cause for any pericarditis/symptoms experienced by the patient in the days following the procedure.
Additional Manufacturer Narrative
D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.E1.Initial reporter phone: (b)(6).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).

• Brand Name: VARIPULSE¿ Bi-Directional Catheter
• Common Device Name: Percutaneous Cardiac Abl Cath for Treatmt of AFib w Irreversible Electroporation
• Manufacturer (Section D): Biosense Webster Inc; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): Biosense Webster Inc (Juarez); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50726562
• Report Number: 3013300026-2026-02983
• Device Sequence Number: 18801281
• Product Code: QZI
• UDI-Device Identifier: 10846835025460
• UDI-Public: 10846835025460
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P240006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: D141201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 52 YR
• Patient Sex: Male