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

Catalog Number	D160904
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with an octaray mapping catheter and an irrigation issue occurred (device used in patient).After re-inserting the octaray mapping catheter into the body, it was noticed that it was no longer irrigating and it was unable to flush.The octaray mapping catheter was removed from the body and it was flushed manually with a syringe, but the issue persisted.The octaray mapping catheter was replaced and the issue was resolved.The procedure continued with no further issues.No patient consequence was reported.Additional information was received.The suspected device for the reported flow/irrigation issue was the catheter.The issue was not noted before the device was used on the patient.It worked fine for the first part of the case.No error was noted on the irrigation pump.It was visually discovered.They ¿flush¿ the catheter prior to insertion into the sheath.They replaced the catheter to resolve the irrigation issue.The correct catheter settings were selected on the generator.No issues with flow rate change at the start of the ablation.No changes were made at the start of the ablation.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) procedure with an octaray mapping catheter and an irrigation issue occurred (device used in patient).The device was returned to johnson & johnson medtech (j&j) for evaluation on 20-aug-2025.Visual inspection and irrigation test of the returned device were performed following j&j procedures.Visual analysis of the returned sample revealed no damage or anomalies on the device.An irrigation test was performed and no issues were observed.The device was flushed, and no obstructed holes were observed during the test.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The irrigation issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use (ifu) contain the following warnings and precautions: a compatible irrigation pump is recommended to ensure proper irrigation flow rate.Before use, verify that the irrigation ports are patent by infusing heparinized normal saline through the catheter and the irrigation tubing.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.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 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: 22798381
• Report Number: 2029046-2025-02681
• Device Sequence Number: 8264638
• Product Code: MTD
• UDI-Device Identifier: 10846835021233
• UDI-Public: (01)10846835021233(11)250411(17)280410(10)31628858L
• 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): 09/12/2025

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: D160904
• Device Lot Number: 31628858L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2025
• 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¿ GENERATOR.; UNK SHEATH.; UNK_NGEN PUMP.
• Patient Sex: Unknown