MAUDE Adverse Event Report: NUVERA MEDICAL NUVISION ICE CATHETER, 10F; CATHETER, ULTRASOUND, INTRAVASCULAR

Catalog Number	FG10593
Medical Device Problem Codes	Overheating of Device (1437); Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an left atrial appendage occlusion (laao) ablation procedure with a nuvision ice catheter, 10f and the device was frequently overheating.As a result the ge p95 ultrasound system would freeze itself.There was no visible smoke or flames.No part of the system melted or carbonized.The catheter was exchanged to continue the case.No patient consequences were reported.
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot 31304957ln and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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).

• Brand Name: NUVISION ICE CATHETER, 10F
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): NUVERA MEDICAL; 140 knowles drive; los gatos CA 95032
• Manufacturer (Section G): NUVERA MEDICAL; 140 knowles drive; los gatos CA
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20688563
• Report Number: 3016516752-2024-00011
• Device Sequence Number: 15274240
• Product Code: OBJ
• UDI-Device Identifier: 00860005688104
• UDI-Public: (01)00860005688104(17)250415(10)31304957LN
• 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
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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: 04/15/2025
• Device Catalogue Number: FG10593
• Device Lot Number: 31304957LN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/16/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNK GE P95 ULTRASOUND SYSTEM.
• Patient Sex: Unknown