MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	R7F282CT
Medical Device Problem Codes	Signal Artifact/Noise (1036); Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and electrical test of the returned device were performed.Visual inspection revealed black foreign material on the tip of the device.The device was connected to the carto 3 system, and it was recognized and visualized correctly.No signal noise or electrical issues were observed.A fourier transform infrared spectroscopy (ft-ir) test was performed to evaluate the black foreign material on the tip.The results of the test was that the material is primarily composed of methacrylate-based material.A manufacturing record evaluation was performed for the finished device number (b)(4) and no internal action related to the complaint was found during the review.The electrical & visualization issue reported by the customer could not be replicated during the product investigation.Other issues or circumstances may have occurred during the use of the device that may have affected its performance.The source of origin of the foreign material remains unknown.The potential cause of the foreign material could not be determined.The carto® 3 system instructions for use (ifu) contain the following information: ecg noise is typically generated as the result of improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify proper connection.It is recommended to turn off the notch filter for this verification.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.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 supraventricular tachycardia (svt) procedure with a decanav for which biosense webster¿s product analysis lab (pal) identified a black foreign material on the tip of the device.Initially, it was reported that the decanav catheter had no signal observed on the carto 3 system when it was connected to the patient interface unit (piu).They could not map and could not assign signals to the catheter.The catheter was visualized on the carto 3 system.When the catheter and cable were replaced, the issue was not resolved.They rebooted the piu without resolution.When they exited the study, and entered the same study, the issue was resolved and the procedure continued.No adverse patient consequence was reported.The visualization and signal noise issues were assessed as non mdr reportable.The risk of patient harm is considered remote.The biosense webster, inc.Pal received the device and per the evaluation completion, a black foreign material was observed on the tip of the device.This was assessed as mdr reportable with an awareness date of 11-jun-2025.

• Brand Name: DECANAV
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): PRECISION CONCEPTS COSTA RICA; saret industrial park building; rio segundo; alajuela 90109 ; CS 90109
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22460245
• Report Number: 2029046-2025-02236
• Device Sequence Number: 12776986
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: (01)10846835008807(17)260126(10)AD24510022
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K080425
• 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
• Report Date (Section B): 07/09/2025

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: 01/26/2026
• Device Catalogue Number: R7F282CT
• Device Lot Number: AD24510022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2025
• Initial Report FDA Received Date: 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2025
• 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: UNK CABLE.; UNK_CARTO 3.; UNK_SMARTABLATE GENERATOR.
• Patient Sex: Unknown