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

Catalog Number	D160901
Medical Device Problem Codes	Coagulation in Device or Device Ingredient (1096); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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 atrial fibrillation (afib) ¿ paroxysmal ablation procedure and the irrigation on the octaray¿ catheter was not connected to the catheter towards the end of the procedure.It is unknown when the irrigation was removed from the catheter.They checked the catheter, and there was some clotting.When the catheter was replaced, the problem was resolved and the case continued.There was no adverse patient consequence.Additional information was received which indicated that the suspected issue is with either the octaray¿ catheter or the octaray¿ irrigation tubing as it was suspected the tubing became disconnected at some point.The device was used in the patient.Ngen¿ pump was in use for ablation.No error was on the irrigation pump as the issue was on the octaray¿ tubing that it was not connected.To resolve this issue, they removed the octaray¿ and replaced it.Correct settings were on the ngen¿ generator and there were no issues with the flow rate at the start of ablation.When the octaray¿ catheter was removed, there were visible clots on the electrodes.The system presented no errors, and the physician noticed the irrigation to the octaray¿ was not connected.It is unknown if the patient is anticoagulated.The physician monitored activated clotting time (act) throughout the case and to the reporter¿s knowledge, it was not abnormal.At times, the octaray¿ was near ablation during the procedure.
Additional Manufacturer Narrative
The biosense webster, inc.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.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: 23919310
• Report Number: 2029046-2025-04344
• Device Sequence Number: 18399561
• Product Code: MTD
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/17/2026

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: D160901
• Device Lot Number: 31745829L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 04/17/2026; 04/17/2026
• Initial Report FDA Received Date: 12/29/2025
• Supplement Report FDA Received Date: 05/14/2026; 06/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2025
• 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: NGEN PUMP.; NGEN¿ RF GENERATOR.
• Patient Sex: Unknown