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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Heart Failure/Congestive Heart Failure (4446)
Date of Event	07/31/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) cardiac ablation procedure with a varipulse bi-directional catheter and the patient expired.After pulse field ablation (pfa) afib ablation they attempted watchman left atrial appendage occlusion (laao) device placement on 31-jul-2026, the patient developed heart failure and passed away.The pfa procedure for afib with trupulse/varipulse was unremarkable.Forty-two (42) pfa applications were delivered, carto mapping was performed with the pentaray catheter, nothing out of the ordinary occurred during the procedure and the patient was stable afterward.Varipulse plus settings of 30ml/min ablation irrigation flow rate, manual switching to 4ml/min idle, inter application delay 10 seconds were used during the procedure.After the pulmonary vein isolation (pvi) portion of the procedure the physician attempted to implant the watchman laao device.This procedure was aborted as it was determined that the patient's appendage was too large for implantation.The patient left the lab on (b)(6) in stable condition.The day following the procedure, (b)(6) 2026, the patient returned to the hospital emergency room with heart failure (previously undiagnosed) and that the patient expired on (b)(6) 2026.Cause of death is believed to be acute heart failure related but cannot be confirmed.
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.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Note: for field d4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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: 50781823
• Report Number: 3013300026-2026-03032
• Device Sequence Number: 10683103
• Product Code: QZI
• UDI-Device Identifier: 10846835025460
• UDI-Public: (01)10846835025460
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: P240006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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
• 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: 08/19/2026
• Initial Report FDA Received Date: 09/15/2026
• 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: Death; Required Intervention
• Patient Sex: Male
• Patient Weight: 202 LB
• Patient Race: White