MAUDE Adverse Event Report: NUVERA MEDICAL NUVISION ICE CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Catalog Number	FG10593
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a left atrial appendage occlusion procedure with a nuvision intracardiac echocardiography (ice) catheter and the catheter kept heating up where the uls system kept shutting off/ freezing due to the catheter heating inside the patient body.The freezing of uls system is a safety mechanism by uls system.Also, the uls system has heat index where nuvision catheter reached 43 degrees.The patient and the doctor were safe, and no complications noted.The issue was resolved by replacing the catheter.The case was continued, and no adverse patient consequence was reported.
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.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
It was reported that a patient underwent a left atrial appendage occlusion procedure with a nuvision intracardiac echocardiography (ice) catheter and the catheter kept heating up where the uls system kept shutting off/ freezing due to the catheter heating inside the patient body.The freezing of uls system is a safety mechanism by uls system.Also, the uls system has heat index where nuvision catheter reached 43 degrees.The patient and the doctor were safe, and no complications noted.The issue was resolved by replacing the catheter.The case was continued, and no adverse patient consequence was reported.Device investigation details: the product was returned to johnson & johnson medtech (j&j medtech) for evaluation.Visual inspection, ultrasound recognition and electrical test were performed following j&j medtech procedures.Visual analysis revealed no damage or anomalies on the device.The device was connected to an ultrasound console, and a high temperature alert appeared on the system.Due to this error, electrical probing at the receptacle was performed on the power, communication, and digital lines, and no issues were found in any of the lines.A manufacturing investigation was performed, and a damage capacitor was identified on the printed circuit board (pcb) that could have caused the issue.An awareness session was performed to avoid this issue.A manufacturing record evaluation was performed for the finished device number lot: 31311087la and no internal action related to the complaint was found during the review.The temperature issue reported by the customer was confirmed.The root cause is the manufacturing process.The instructions for use (ifu) states: the maximum allowable probe surface temperature is 43°c.The ge ultrasound system continuously monitors the probe surface temperature from a thermistor located within the tip of the probe.If necessary, the system will adjust energy delivery to the transducer to assure the probe surface temperature never exceeds 43° c.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: NUVISION ICE CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): NUVERA MEDICAL; 140 knowles drive; los gatos CA 95032
• 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: 22161271
• Report Number: 3016516752-2025-00005
• Device Sequence Number: 15324451
• Product Code: OBJ
• UDI-Device Identifier: 00860005688104
• UDI-Public: (01)00860005688104(17)260425(10)31311087LA
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K201775
• 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
• Report Date (Section B): 08/27/2025

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 Expiration Date: 04/25/2026
• Device Catalogue Number: FG10593
• Device Lot Number: 31311087LA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 07/31/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 08/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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