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

Catalog Number	FG10593
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Arrest (1762); Cardiac Perforation (2513)
Date of Event	07/09/2025
Type of Reportable Event	Death
Event or Problem Description
It was reported that during a watchman left atrial appendage closure while using a nuvision ice catheter, the patient experienced pressure drop, pericardial effusion, and cpr was performed--after which, the patient passed away.It was reported that during a watchman left atrial appendage closure procedure, the physician had difficulty crossing the septum with the nuvision catheter and after approximately 40 minutes, the patient had a pressure drop.It was observed by ultrasound that the patient had a large pericardial effusion around the right atrium and right ventricle.They performed a pericardial effusion and cpr.Over 2 liters was removed from the pericardial space.Surgical intervention was considered, but the family of the patient declined as the patient was a dnr (do not resuscitate).The patient then passed away.Information received indicated the physician¿s opinion on the cause of death was that the nuvision catheter perforated the right atrium.
Additional Manufacturer Narrative
D4: udi: as the lot number for the device involved in the event was not provided, the full udi is currently not available.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.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition.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, 10F
• 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: 22689717
• Report Number: 3016516752-2025-00007
• Device Sequence Number: 18427645
• Product Code: OBJ
• UDI-Device Identifier: 00860005688104
• UDI-Public: 00860005688104
• 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): 08/01/2025

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
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2025
• Initial Report FDA Received Date: 08/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Outcome Attributed to Adverse Event: Death; Life Threatening; Required Intervention
• Patient Age: 83 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White