MAUDE Adverse Event Report: Biosense Webster Inc EZ Steer ThermoCool NAV; Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

Catalog Number	BNI75TCDFH
Medical Device Problem Codes	Device Sensing Problem (2917); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	09/02/2026
Type of Reportable Event	Serious Injury

• Brand Name: EZ Steer ThermoCool NAV
• Common Device Name: Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter
• 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: 50941066
• Report Number: 3013300026-2026-03206
• Device Sequence Number: 10759583
• Product Code: OAD
• UDI-Device Identifier: 10846835003338
• UDI-Public: (01)10846835003338(17)290318(10)31885072M
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/29/2026

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: BNI75TCDFH
• Device Lot Number: 31885072M
• 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: 09/04/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2026
• 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: Female
• Patient Race: Asian