MAUDE Adverse Event Report: Biosense Webster Inc OCTARAY Mapping Catheter; Catheter, Intracardiac Mapping, High-Density Array

Catalog Number	D160903
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a paroxysmal atrial fibrillation ablation with an octaray mapping catheter and the patient experienced a pericardial effusion that required heparin reversed and a pericardiocentesis was performed.Slightly after the transseptal was performed, the patient had a drop in blood pressure and a pericardial effusion was confirmed with intracardiac echocardiography (ice).The medical intervention performed was that heparin was reversed and a pericardiocentesis was performed.The procedure was aborted.The last known patient status was stable.The physician believed that the pericardial occurred during the transseptal process.The octaray mapping catheter had been advanced into the body shortly after transseptal access and that a left atrial pre-map was had been performed using the octaray mapping catheter.No ablation had been performed.The smart touch sf de catheter was not advanced into the body or used for ablation.The carto 3 system was used for mapping.Multiple attempts have been made to obtain clarification of this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation 14-sep-2026.The 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 reference number: (b)(4).

• Brand Name: OCTARAY Mapping Catheter
• Common Device Name: Catheter, Intracardiac Mapping, High-Density Array
• 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: 50869000
• Report Number: 3013300026-2026-03116
• Device Sequence Number: 18810033
• Product Code: MTD
• UDI-Device Identifier: 10846835021127
• UDI-Public: (01)10846835021127(17)290326(10)31911368L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• 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: D160903
• Device Lot Number: 31911368L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• 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: 09/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/27/2026
• 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: Life Threatening; Required Intervention
• Patient Sex: Unknown