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

Catalog Number	D160901
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a octaray mapping catheter and the irrigation lumen was occluded and irrigation did not flow.(the irrigation was found to be flowing at the start of use.) after ablating the posterior wall, when octaray was removed before cti (cavotricuspid isthmas) ablation.The occlusion alarm sounded twice.For the first alarm, the three-way stopcock was opened, performed a flush to confirm patency, and then restarted irrigation.After a short time the alarm sounded a second time, so the catheter was removed from the patient¿s body and the occlusion was confirmed.Since the issue was related to octaray, it was not related to the generator.The irrigation issue was noted after the device had already been used on the patient.After the occlusion was confirmed, the procedure was completed without using octaray--the catheter was replaced.No patient consequences were reported.
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).
Additional Manufacturer Narrative
On 11-dec-2025, 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
On 11-feb-2026, the product investigation was completed.It was reported that a patient underwent a cardiac ablation procedure with a octaray mapping catheter and the irrigation lumen was occluded and irrigation did not flow.(the irrigation was found to be flowing at the start of use.) after ablating the posterior wall, when octaray was removed before cti (cavotricuspid isthmas) ablation.The occlusion alarm sounded twice.For the first alarm, the three-way stopcock was opened, performed a flush to confirm patency, and then restarted irrigation.After a short time the alarm sounded a second time, so the catheter was removed from the patient¿s body and the occlusion was confirmed.Since the issue was related to octaray, it was not related to the generator.The irrigation issue was noted after the device had already been used on the patient.After the occlusion was confirmed, the procedure was completed without using octaray--the catheter was replaced.No patient consequences were reported.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection and irrigation test of the returned device were performed in accordance with j&j medtech procedures.Visual analysis of the returned device revealed that no damage or anomalies were observed on the device.An irrigation test was performed, and irrigation could not be performed, therefore a manufacturing investigation was initiated.A manufacturing investigation was performed, and it was determined this issue is related to a condition found on the irrigation tube in the tip area, the component was defective as it caused the irrigation tube to bend when the device was deflected.The supplier was notified about this issue.A manufacturing record evaluation was performed for the finished device 31731875l, and no internal action was found during the review.The issue reported by the customer was confirmed.The potential cause was traced to manufacturing.This product issue will be addressed through j&j medtech's quality system.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: 23723082
• Report Number: 2029046-2025-04008
• Device Sequence Number: 10464874
• Product Code: MTD
• UDI-Device Identifier: 10846835021141
• UDI-Public: (01)10846835021141(11)250804(17)280803(10)31731875L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2026

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: 31731875L
• 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: 11/07/2025
• Supplement Date Received by Manufacturer: 12/11/2025; 02/11/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 01/07/2026; 03/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/04/2025
• 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: TERUFUSION INFUSION PUMP.
• Patient Sex: Unknown