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

Catalog Number	D160903
Medical Device Problem Codes	Obstruction of Flow (2423); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 27-jan-2026, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.(b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an octaray catheter and a fluid leak occurred.It was reported that the octaray catheter was advanced into the body when they noticed it was not irrigating (the liquid was leaking back out).The caller noted the catheter was removed from the body and the physician stated the plastic connector tube for the irrigation was broken.The catheter was replaced and the issue resolved.The procedure continued with no further issues.There was no patient consequence.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an octaray catheter and a fluid leak occurred.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection and irrigation test of the returned device were performed in accordance with j&j procedures.Visual analysis of the returned device revealed that the luer valve was damaged.The valve was observed deformed and mashed and did not fit correctly to the tubing, allowing water to leak.An irrigation test was not possible to be performed due to the damage on the luer valve.The damage observed could be related to the manipulation of the device during the procedure, however, this cannot be conclusively determined.A manufacturing record evaluation was performed and no internal action related to the complaint were found during the review.The leak and damage issues reported by the customer were confirmed.The potential cause of the issue cannot be conclusively determined.The instructions for use contain the following warning and precautions: purge the catheter and the irrigation tubing with heparinized normal saline prior to insertion of the catheter into the patient.Inspect the irrigation saline for air bubbles prior to its use in the procedure.Air bubbles in the irrigation saline may cause emboli.Always maintain a constant heparinized normal saline infusion to prevent coagulation within the lumen of the catheter.Do not use the catheter without irrigation flow.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: OCTARAY 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: 24196128
• Report Number: 2029046-2026-00330
• Device Sequence Number: 18158881
• Product Code: MTD
• UDI-Device Identifier: 10846835021127
• UDI-Public: (01)10846835021127(11)251106(17)281105(10)31807096L
• 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

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: D160903
• Device Lot Number: 31807096L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 02/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• 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 RF GENERATOR.
• Patient Sex: Unknown