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

Catalog Number	FG10593
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Perforation (2513)
Date of Event	09/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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
During a watchman procedure, while doing a demo of the nuvision ultrasound catheter, the patient experienced cardiac perforation, and the surgery team was called in for a pericardial window.The patient was stable.It was reported that while they were doing a demo with a nuvision ultrasound catheter, they noticed a baseline effusion in the patient and the physician decided to proceed with the case.They crossed transseptal "fine" with the nuvision¿ ultrasound catheter into the left atrium.The nuvision ultrasound catheter was used for imaging to size the watchman.They noticed the appendage was large and "weird." they proceeded to place the watchman sheets and when positioning it, the watchman representative stated that it was too deep in the appendage, and they all agreed.The physician pulled the sheath back the most minimal amount and deployed the watchman.The patient¿s blood pressure "plummeted", the physician retracted the nuvision ultrasound catheter out of the heart, turned on transesophageal echocardiogram (tee), looked and noticed a huge effusion.The watchman was deployed into the pericardium, and the injury was a large cardiac perforation, that was discovered by the drop in the blood pressure, tee and fluro with contrast.The x-ray confirmed the injury.The case was aborted.The operation room team was called in for a fix with a "window." the patient¿s last known status was stable.The physician believed that the nuvision ultrasound catheter caused an initial 4mm hole in the appendage and that the watchman went through that hole and dilated it open.The nuvision ultrasound catheter was never in the appendage.Additional information was received which indicated that the physician¿s opinion on the cause of this adverse event was that the physician was blaming the nuvision catheter for causing a small perforation in the left atrial appendage (laa) before placing the watchman sheath.However, everyone else in the room agreed that the catheter was never in the laa the entire case and was only floating in the left atrium (la).The intervention provided was the patient stabilized with a pericardial window.The outcome of the adverse event was improved.The patient required extended hospitalization for a few days to monitor.Normally, they are discharged the same day, so this was an extended stay.This was an ultrasound only case, so no generator/pump were used, left atrial appendage occlusion (laao) only case.
Additional Manufacturer Narrative
The lot number has been provided.Therefore, fields d4.Lot, d4.Expiration date, and h4.Device manufacture date have been populated.A manufacturing record evaluation was performed for the finished device lot number 31551761l and no internal action related to the complaint was found during the review.Correction to the initial: the h4.Primary udi number has been updated with full udi.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 ; 9497882078
• MDR Report Key: 23316944
• Report Number: 3016516752-2025-00009
• Device Sequence Number: 5827029
• Product Code: OBJ
• UDI-Device Identifier: 00860005688104
• UDI-Public: (01)00860005688104(17)270130(10)31551761L
• 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): 11/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: FG10593
• Device Lot Number: 31551761L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/18/2025
• Supplement Date Received by Manufacturer: 10/27/2025
• Initial Report FDA Received Date: 10/16/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2025
• 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: WATCHMAN DEVICE
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Sex: Female