MAUDE Adverse Event Report: Biosense Webster Inc OPTRELL Mapping Catheter with TRUEref Technology; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	D142901
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	06/19/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a clinical study atrial fibrillation (afib) case, the patient suffered complete heart block requiring surgical intervention.Patient received an index cardiac ablation for ventricular tachycardia.On (b)(6) 2026, patient experienced complete heart block (ae#1), categorized as moderate and serious, defined by hospitalization with an admission date of (b)(6) 2026 and a discharge date of (b)(6) 2026.Relationship to study device is probable (navistar thermocool and optrell catheters) and relationship to the index study procedure is probable.The adverse event is anticipated.The outcome is resolved with an end date of (b)(6) 2026.Intervention was surgery (upgrade to a crt-d "[cardiac resynchronization therapy defibrillator]" system.Patient had already a 1 chamber -icd "[implantable cardioverter-defibrillator]").
Additional Manufacturer Narrative
E1.Initial reporter phone: (b)(6).An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot 31599752m 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 reference number: (b)(4).

• Brand Name: OPTRELL Mapping Catheter with TRUEref Technology
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 50871202
• Report Number: 3013300026-2026-03119
• Device Sequence Number: 9314652
• Product Code: MTD
• UDI-Device Identifier: 10846835025828
• UDI-Public: (01)10846835025828(17)280309(10)31599752M
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K230253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/23/2026

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: D142901
• Device Lot Number: 31599752M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2026
• Initial Report FDA Received Date: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2025
• 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: Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male