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 Codes	Cardiac Arrest (1762); Tachycardia (2095); Ventricular Fibrillation (2130)
Date of Event	02/20/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
On 11-mar-2026, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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).
Event or Problem Description
A patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a optrell mapping catheter with trueref technology and while mapping with the device, the patient experienced blood pressure dropped/hypotension, ventricular tachycardia, ventricular fibrillation treated with cardioversion, cpr and epinephrine administration.The report indicated that after mapping the left ventricle with the optrell catheter, the physician induced ventricular tachycardia with rv pacing.Anesthesiologist then noted that the patient's blood pressure dropped/hypotension.The staff cardioverted the patient 7 or 8 times without success.The patient's rhythm then degraded to ventricular fibrillation.Cpr was performed, along with several defibrillation attempts and epinephrine administration.The patient's rhythm was eventually restored to sinus rhythm.The patient is currently stable.
Additional Manufacturer Narrative
A patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a optrell mapping catheter with trueref technology and while mapping with the device, the patient experienced blood pressure dropped/hypotension, ventricular tachycardia, ventricular fibrillation treated with cardioversion, cpr and epinephrine administration.Device evaluation details: the product was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection and revision of all features were performed following johnson & johnson medtech procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed.No magnetic, force, irrigation, deflection, temperature or electrical issues were found during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.As part of the johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.The manufacturer's ref.#: (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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 24606801
• Report Number: 2029046-2026-00854
• Device Sequence Number: 18398696
• Product Code: DRF
• UDI-Device Identifier: 10846835025828
• UDI-Public: (01)10846835025828(11)250916(17)280915(10)31736711M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230253
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• 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: D142901
• Device Lot Number: 31736711M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2025
• 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: Required Intervention; Life Threatening
• Patient Sex: Unknown