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

Catalog Number	D160906
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an octaray mapping catheter which was unable to be flushed after ablation.It was reported that there was an irrigation issue involving the octaray catheter.The caller reported that after delivering pulsed field ablation (pfa) with the farawave pfa catheter, they were unable to successfully flush the octaray catheter.They replaced the octaray catheter and the issue was resolved.The procedure continued.There was no patient consequence.Additional information received indicated the suspected device with the issue is the catheter, not the bd alaris pump.The catheter was hooked up to a pressure drip, which was working properly, but nothing would flush through the catheter, even trying with a syringe.The device was irrigated properly initially, therefore used on the patient, but it did not irrigate after switching from pfa back to mapping with octaray mapping catheter.There was no error on the pump.The catheter was flushed outside the body before inserting back into the body and it was discovered that it could no longer flush.To troubleshoot, we confirmed that there was flow through the pump and pressure tubing.The only thing that wouldn¿t flow through was the catheter.We tried flushing the catheter with a syringe.That did not work.We replaced the catheter with a new one and the issue resolved.
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 ref.# (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: 50867250
• Report Number: 3013300026-2026-03115
• Device Sequence Number: 9314068
• Product Code: MTD
• UDI-Device Identifier: 10846835021134
• UDI-Public: (01)10846835021134(11)260518(17)290517(10)31944605L
• 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

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D160906
• Device Lot Number: 31944605L
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/23/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2026
• Supplement Date Received by Manufacturer: 09/23/2026
• Initial Report FDA Received Date: 09/23/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/18/2026
• 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
• Patient Sex: Unknown