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	Stroke/CVA (1770)
Date of Event	08/19/2026
Type of Reportable Event	Serious Injury

• 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: 50744499
• Report Number: 3013300026-2026-03002
• Device Sequence Number: 13317335
• Product Code: QZI
• UDI-Device Identifier: 10846835025460
• UDI-Public: (01)10846835025460(17)270419(10)31883416L
• 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
• Remedial Action: Notification
• Type of Report: Initial
• Report Date (Section B): 09/11/2026

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
• Device Lot Number: 31883416L
• 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: 08/25/2026
• Initial Report FDA Received Date: 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/20/2026
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3013300026-01/17/2025-00
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Male
• Patient Race: Asian