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 Code	Cardiac Tamponade (2226)
Date of Event	08/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a varipulse bi-directional catheter and the patient experienced a cardiac tamponade which required pericardiocentesis.Transseptal puncture was performed with a radiofrequency (rf) needle (boston scientifics).A total of 16 ablations by pulse field ablation was done.The procedure was completed without issue.After sheath removal, the patient's blood pressure decreased, and a cardiac tamponade was discovered.Pericardial drainage was performed, and the blood pressure subsequently stabilized.The patient was under observation and has fully recovered.Physician's judgment on health hazard is that it was non-serious (moderate/minor).The physician's comment regarding relationship between the event and the product is that as the varipulse catheter was used only within the left atrium and the drained blood was venous blood; the issue was considered unlikely to be related to the device.The physician believes it was procedure related.There were no abnormalities observed prior to or during product use.
Additional Manufacturer Narrative
Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device number lot 31888693l and no internal actions related to the complaint were found during the review.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 ref.# (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: 50935392
• Report Number: 3013300026-2026-03196
• Device Sequence Number: 10734839
• Product Code: QZI
• UDI-Device Identifier: 10846835025460
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Type of Report: Initial

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
• Device Lot Number: 31888693L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2026
• 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: Required Intervention; Life Threatening
• Patient Sex: Unknown
• Patient Race: Asian