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

Catalog Number	FG10593
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that a patient underwent a watchman procedure with a nuvision intracardiac echocardiography (ice) catheter and the distal tip of the catheter came apart from the shaft of the catheter.The catheter was replaced and the case continued.There was no adverse patient consequence.
Additional Manufacturer Narrative
Correction to the initial report: the correct d4.Primary udi number is (b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a watchman procedure with a nuvision intracardiac echocardiography (ice) catheter and the distal tip of the catheter came apart from the shaft of the catheter.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Visual inspection was performed following j&j medtech procedures.Visual analysis revealed that the tip was separated from the shaft.There was reddish material in the tip area and the shaft was bent.A manufacturing investigation was performed due to the separation of the tip.A fourier transform infrared spectroscopy (ft-ir) and a scanning electron microscopy (sem) with energy-dispersive x-ray spectroscopy test was requested for the tip of the device, and it was concluded that there was insufficient adhesive at the post of the tip.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The broken tip issue reported by the customer was confirmed.The root cause for the separation of the tip was the incorrect application of adhesive in the post of the tip, related to the manufacturing process.The potential cause of the shaft bent could be related to the manipulation of the device after the procedure, however, this could not be conclusively determined.An internal corrective action was created to assure the correct application of the adhesive in the tip area.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): NUVERA MEDICAL; 140 knowles drive; los gatos CA
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22909243
• Report Number: 3016516752-2025-00008
• Device Sequence Number: 8932242
• Product Code: OBJ
• UDI-Device Identifier: 00860005688104
• UDI-Public: (01)00860005688104(17)250812(10)31409309L
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 12/31/2025

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: 08/12/2025
• Device Catalogue Number: FG10593
• Device Lot Number: 31409309L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2025
• Supplement Date Received by Manufacturer: 12/09/2025; 12/31/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 12/31/2025; 12/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2024
• 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