MAUDE Adverse Event Report: Biosense Webster Inc OPTRELL; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	D140901
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/18/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 31274523m 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.\ \ based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition.\ \ if the product is received at a later date, the investigation will be updated as applicable.\ \ 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).
Event or Problem Description
It was reported that a patient underwent an ablation procedure with an optrell catheter and the patient experienced cardiac tamponade.\ \ after premature ventricular contraction procedure, approximately one hour after the optrell use, during the brockenbrough method (a transseptal puncture technique) was about to be performed, pericardial effusion and a decrease in blood pressure were confirmed.There was no malfunction or breakage of the biosense webster inc.(bwi) product itself.Since no bwi product malfunction was observed, after the unknown treatment for tamponade, the procedure was continued and completed without issue.The patient¿s outcome has improved.\ \ physician assessment of the health hazard is non-serious (moderate/minor).The physician¿s opinion on the cause of the event is that it is procedure related.The physician commented that the issue might have occurred either due to the aiv catheter wire or while advancing the optrell catheter into the right ventricular outflow tract.There were no abnormalities observed prior to or during use of the product.

• Brand Name: OPTRELL
• 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: 50763117
• Report Number: 3013300026-2026-03013
• Device Sequence Number: 21172612
• Product Code: DRF
• UDI-Device Identifier: 10846835023015
• UDI-Public: (01)10846835023015(17)270314(10)31274523M
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K211438
• 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): 09/14/2026

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: D140901
• Device Lot Number: 31274523M
• 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: 08/18/2026
• Initial Report FDA Received Date: 09/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Female
• Patient Race: Asian