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

Catalog Number	D160906
Medical Device Problem Codes	Failure to Sense (1559); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	07/15/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a octaray mapping catheter and the patient experienced a cardiac tamponade which required pericardiocentesis.While mapping the left atrium, the catheter went into the right atrium without them noticing it.When the catheter went into the coronary sinus (cs), the medical team realized the catheter was no longer in the left atrium.When they tried to go back into the left atrium, they got a lot of resistance from the catheter.At that point, they noticed the carto 3 system displayed a magnetic distortion error on the octaray catheter.Then the patient¿s blood pressure went from stable blood pressure to 43 over 37.The intracardiac echocardiogram (ice) catheter was pulled from the left atrium into the right atrium and that is when they noticed a large pericardial effusion, so they removed the octaray catheter and the 13 french agilis sheath from the body.The pericardial effusion was confirmed by ice (intracardiac echocardiography).Medical intervention provided was pericardiocentesis and 5880cc of fluid was removed before the patient was taken to cardiothoracic (ct) surgery.Ct surgeon confirmed that there was a perforation in the cs (coronary sinus) and the patient was stable and "doing well" after ct surgery.No ablation was completed during the procedure.Transseptal puncture was performed with a brk needle + safesept.The physician believes the perforation happened when the octaray/agilis were attempted to be advanced across the transseptal after falling out of the left atrium while mapping.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation.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: 50216862
• Report Number: 3013300026-2026-02586
• Device Sequence Number: 17666946
• Product Code: MTD
• UDI-Device Identifier: 10846835021134
• UDI-Public: (01)10846835021134(17)290422(10)31927847L
• 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,Followup
• Report Date (Section B): 09/24/2026

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: D160906
• Device Lot Number: 31927847L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/06/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2026
• Supplement Date Received by Manufacturer: 09/01/2026
• Initial Report FDA Received Date: 08/11/2026
• Supplement Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2026
• 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