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

Catalog Number	FG10593
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an left atrial appendage occlusion (laao) watchman ablation procedure with a nuvision ice catheter, 10f and post procedure the bwi product analysis lab identified a kink and a breakage on the tip with reddish brown material inside.During the procedure, after insertion there were bright lines at the top of the ultrasound screen.The catheter cable was reseated without resolution.The caller stated that the ultrasound machine kept freezing.When the catheter was studied under fluoro, the tip of the catheter was bent.The catheter was replaced and the issue was resolved.The caller confirmed that the catheter did not appear bent when removed from the sterile packaging.The case continued.No patient consequences were reported.
Additional Manufacturer Narrative
The product investigation was completed.Device evaluation 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 inspection revealed a kink and a breakage on the tip with reddish brown material inside.The device was connected to an ultrasound console, and it was recognized and visualized correctly.Afterwards, electrical probing at the receptacle was performed and no readings were found on two cw lines and a transducer element.The open line on the transducer element could be related to the issue reported by the customer; however, this cannot be conclusively determined a manufacturing record evaluation was performed for the finished device lot number 31256480ln and no internal action was found during the review.The poor image reported by the customer was confirmed.The potential cause for the open circuit could not be determined.The instructions for use (ifu) contain the following information: do not disconnect the catheter nor the cable from the ge ultrasound system while scanning.If necessary, it is recommended to disconnect the system connector of the cable from the system in the freeze mode.The bent tip reported by the customer was confirmed.The potential cause of the tip breakage and the reddish material could be related to the handling of the device during the procedure; however, this cannot be conclusively determined.The instructions for use (ifu) contain the following information: hold the catheter tip 1 to 2 cm from the introducer valve and feed it into the introducer slowly to prevent buckling of the catheter tip.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through the quality system.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): NUVERA MEDICAL; 140 knowles drive; los gatos CA
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20794843
• Report Number: 3016516752-2024-00013
• Device Sequence Number: 20806832
• Product Code: OBJ
• UDI-Device Identifier: 00860005688104
• UDI-Public: (01)00860005688104(17)250222(10)31256480LN
• 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): 11/27/2024

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: 02/22/2025
• Device Catalogue Number: FG10593
• Device Lot Number: 31256480LN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2024
• Initial Report FDA Received Date: 11/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/23/2024
• 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