MAUDE Adverse Event Report: NUVERA MEDICAL NUVISION ICE CATHETER, 10F; CATHETER, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING

Model Number	FG10593
Medical Device Problem Codes	Break (1069); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
A patient underwent an ablation procedure with a nuvision ice catheter for which biosense webster¿s product analysis lab identified an exposed braid wire was noted approximately 11.2 cm from the distal end of the device.The finding was identified on (b)(6) 2022.During the procedure, the carto 3 system and ultrasound system were displaying poor image quality when the nuvision catheter was connected to the ultrasound machine.The medical team replaced the catheter, and the issue was resolved.The procedure was continued.The image quality issue is not mdr-reportable.The exposed braid wire is mdr-reportable.
Additional Manufacturer Narrative
The product investigation was completed.Device evaluation details: visual analysis of the returned device revealed that an exposed braid wire was noted approximately 11.2 cm from the distal end of the device.The device was electrically probed in the receptacle and eam manipulation, and acoustically scanned tested.No abnormalities were found.Lot history record review was performed for lot#: 0246.All records were found to be completed and no internal actions related to the nature of the complaint were found.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendations the magnetic sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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, ELECTRODE RECORDING OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): NUVERA MEDICAL; 140 knowles drive los gatos; los gatos CA 95032
• Manufacturer (Section G): NUVERA MEDICAL; 140 knowles drive los gatos ca; los gatos CA 95032
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15262260
• Report Number: 3016516752-2022-00002
• Device Sequence Number: 5745598
• Product Code: DRF
• UDI-Device Identifier: 00860005688104
• UDI-Public: 00860005688104
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/19/2022

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: 03/25/2023
• Device Model Number: FG10593
• Device Catalogue Number: FG10593
• Device Lot Number: 0246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 08/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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