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	Dyspnea (1816)
Date of Event	07/14/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a varipulse catheter and the patient experienced shortness of breath that required oxygen and pulmonology consultation.The patient underwent an ablation procedure on (b)(6) 2026.On (b)(6) 2026 the patient experienced shortness of breath.It was deemed not related to the ablation devices or procedure.It was considered non-serious, however required medial intervention which included transesophageal echocardiography (tee) echo and home oxygen at 3 liters per nasal cannula.The patient outcome was reported as not recovered/not resolved and pulmonology advised a 4 month follow-up.
Additional Manufacturer Narrative
Device investigation details: 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.However, if the product is received at a later date, the investigation will be updated as applicable.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: 50260551
• Report Number: 3013300026-2026-02637
• Device Sequence Number: 15986460
• Product Code: QZI
• UDI-Device Identifier: 10846835025460
• UDI-Public: (01)10846835025460
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P240006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional
• Type of Report: Initial,Followup

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: 07/16/2026
• Supplement Date Received by Manufacturer: 08/18/2026
• Initial Report FDA Received Date: 08/14/2026
• Supplement Report FDA Received Date: 09/10/2026
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 180 LB
• Patient Race: White