MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NUVISION NAV ULTRASOUND CATHETER; CATHETER, ULTRASOUND, INTRAVASCULAR

Catalog Number	FG12081
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a nuvision nav ultrasound catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the tip area.It was initially reported by the customer that when connecting the nuvision nav catheter, the s70 ultrasound machine had a red error "probe not recognized".No errors on the carto 3 system.The catheter connections were reseated, and different ports were used, without resolution.The catheter was replaced, and the issue resolved.The procedure was continued and completed.There was no patient consequence.The customer's reported recognition issue is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On (b)(6) 2025, the bwi pal revealed that a visual inspection of the returned device found a hole in the tip area.The finding was reviewed and assessed the issue of a ¿hole¿ as an mdr reportable malfunction since the integrity of the device has been compromised.
Additional Manufacturer Narrative
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 analysis revealed a hole in the tip area.The device was connected to an ultrasound console and the error ¿4dice probe in connector 0 not accepted by system¿ appeared on the system.Due to this error, electrical probing at the receptacle was performed on the power, communication, and digital lines; and no readings were on the lines cw_5, cw_6.These open lines could be related to the failure mode observed during the analysis.A manufacturing record evaluation was performed and no internal actions related to the reported complaint condition were identified.The ultrasound recognition issue reported by the customer was confirmed.The potential cause of the open circuits could not be determined.The potential cause of the hole at the tip could be related to the manipulation of the device during the procedure, however, this could not be conclusively 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; do not bend, kink, stretch, or forcefully wipe the catheter.These actions may damage the catheter.Do not use forceps or any other mechanical tool to grip the catheter; do not advance the catheter if resistance is encountered.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: mechanical problem identified (c07) / investigation conclusions: cause not established (d15) / component code: tip (g04129) were selected as related to the hole in the catheter tip identified by bwi pal.Investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: electrical lead/wire (g02015) were selected as related to the customer's reported catheter recognition issue.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 ref.# pc-002009572.

• Brand Name: NUVISION NAV ULTRASOUND CATHETER
• Common Device Name: CATHETER, ULTRASOUND, INTRAVASCULAR
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• 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: 24127304
• Report Number: 2029046-2026-00252
• Device Sequence Number: 18738838
• Product Code: OBJ
• UDI-Device Identifier: 10846835026559
• UDI-Public: (01)10846835026559(17)260710(10)31694513L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K241540
• 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

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: 07/10/2026
• Device Catalogue Number: FG12081
• Device Lot Number: 31694513L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/24/2025
• Initial Report FDA Received Date: 01/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2025
• 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: CARTO 3 SYSTEM.
• Patient Sex: Unknown