MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NUVISION ULTRASOUND CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Catalog Number	FG12081
Medical Device Problem Codes	Overheating of Device (1437); Excessive Heating (4030)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/19/2026
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 a ventricular tachycardia ablation procedure with a nuvision ultrasound catheter and the probe was overheating.A warning displayed, indicating it was getting too hot, it froze and then cut off.The catheter and cable were reseated without resolution.The swiftlink was reseated without resolution.The catheter would cool, and when turned back on the issue repeated.The catheter was replaced and the issue resolved.The procedure continued with no further issues.No patient consequences were reported.
Additional Manufacturer Narrative
On 18-mar-2026, the product investigation was completed.Per internal review on that same day, it was identified that the product receipt of 11-mar-2026 was mistakenly omitted from the initial report.Section d9 has been updated accordingly on this report.It was reported that a patient underwent a ventricular tachycardia ablation procedure with a nuvision ultrasound catheter and the probe was overheating.A warning displayed, indicating it was getting too hot, it froze and then cut off.The catheter and cable were reseated without resolution.The swiftlink was reseated without resolution.The catheter would cool, and when turned back on the issue repeated.The catheter was replaced and the issue resolved.The procedure continued with no further issues.No patient consequences were reported.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection evaluation and ultrasound test of the returned device was performed following j&j medtech procedures.Visual inspection of the returned sample revealed no damage or anomalies.The device was connected to the ultrasound console and the device was correctly recognized and visualized.Also, no high temperature errors were displayed on the screen.In addition, simultaneously a thermometer was connected to the device handle, and the temperature values pass the specifications.An overheating handle was not detected during the analysis.A manufacturing record evaluation was performed for the finished device (b)(6) number, and no internal actions related to the reported complaint condition were identified.The temperature and handle warm issue reported by the customer could not be confirmed during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of the johnson & johnson medtech 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: NUVISION ULTRASOUND CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• 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: 24607574
• Report Number: 2029046-2026-00860
• Device Sequence Number: 13155589
• Product Code: OBJ
• UDI-Device Identifier: 10846835026559
• UDI-Public: (01)10846835026559(17)260820(10)31684525L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K241540
• 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): 04/08/2026

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 Expiration Date: 08/20/2026
• Device Catalogue Number: FG12081
• Device Lot Number: 31684525L
• 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: 02/19/2026
• Supplement Date Received by Manufacturer: 03/18/2026
• Initial Report FDA Received Date: 03/16/2026
• Supplement Report FDA Received Date: 04/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2025
• 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
• Patient Sex: Unknown