MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number	D160904
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	12/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
During an atrial tachycardia ablation procedure, after mapping with an octaray catheter, the patient experienced cardiac perforation and pericardial effusion treated with pericardiocentesis.The patient was stable.At 11:33 am, the transseptal was performed.After mapping in the left atrium with the octaray catheter, it was about to be exchanged with the qdot micro catheter.Around this time (12:15 pm), the patient experienced a drop in blood pressure and a moderate effusion was first noticed on intracardiac echo (ice).An interventional physician was brought in and a pericardiocentesis was performed.The patient was stable at the time of the call; further intervention was undetermined.No ablation was performed prior to the complication.The products used were qdot micro catheter, octaray catheter, soundstar catheter, vizigo sheath, cs catheter, and carto 3 system.
Additional Manufacturer Narrative
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).
Additional Manufacturer Narrative
On 31-dec-2025, bwi received additional information regarding the event.The physician¿s opinion on the cause of this adverse event was possibly from catheter exchange in the transeptal sheath.The outcome of the adverse event was the patient fully recovered (no residual effects).The patient required extended hospitalization because of extra two days of monitoring.The relevant tests/laboratory data was tee (transesophageal echocardiogram) at the time of incident, unremarkable for clear causation for perforation.Other relevant history/preexisting conditions for the patient was svt (supraventricular tachycardia).A transseptal puncture was performed.Prior to noting the pe (pericardial effusion), ablation was not performed.No evidence of steam pop was ntoed--as there was no ablation performed.The drop in blood pressure was noticed by lab staff during the catheter exchange from the octaray to the qdot catheter.The flow setting was normal low flow setting while in la (left atrium).The patient did not require cardiac surgery.No error messages were observed on biosense webster equipment during the procedure.Ngen generator was available for the procedure.Section a of this supplemental report was updated as well (the patient is a white, cisgender female).On 9-jan-2026, the product investigation was completed as the complaint device was not returned.Device investigation details: 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 31775250l 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 additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23886795
• Report Number: 2029046-2025-04293
• Device Sequence Number: 4706618
• Product Code: MTD
• UDI-Device Identifier: 10846835021233
• UDI-Public: (01)10846835021233(11)251001(17)280930(10)31775250L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K193237
• 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
• Report Date (Section B): 12/24/2025

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: D160904
• Device Lot Number: 31775250L
• 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: 12/01/2025
• Supplement Date Received by Manufacturer: 12/31/2025
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/01/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM.; SOUNDSTAR ECO SMS 8F CATHETER.; UNK_CARTO VIZIGO SHEATH.
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White