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

Catalog Number	BD710DF282RTS
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product investigation was completed.Device evaluation details: the device was returned to 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 analysis revealed foreign material in the dome area.An electrical test was performed and the values were within specifications, no signal noise or electrical issues were observed during the test.Then, a fourier transform infrared spectroscopy (ftir) was performed and revealed that the unknown material shows vibrations correspondent to methacrylate-based material, slight variations suggest material modifications; however, source of origin and cause of changes remains unknown.A manufacturing record evaluation was performed for the finished device 31570818m number, and no internal actions related to the reported complaint condition were identified.The noise issue and current leakage 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 foreign material was unrelated to the reported event, the potential cause could be related to the manipulation of the device during the procedure; however, this could not be conclusively determined.The carto® 3 system instructions for use (ifu) contain the following information: ecg (electrocardiogram) 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 product complaint 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).
Event or Problem Description
It was reported that the patient underwent an atrial fibrillation - paroxysmal ablation procedure with a webster® cs bi-directional catheter and post procedure the bwi product analysis lab revealed foreign material in the dome area.During the procedure, there was noise displayed on the distal bipolar signals for the webster® cs bi-directional catheter, on the carto¿ 3 and recording system.The cable was replaced without resolution.The webster® cs bi-directional catheter was replaced and the issue was resolved.The procedure continued.No patient consequences were reported.

• Brand Name: WEBSTER CS CATHETER
• Common Device Name: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• 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: 22310431
• Report Number: 2029046-2025-02052
• Device Sequence Number: 15435007
• Product Code: DRF
• UDI-Device Identifier: 10846835002416
• UDI-Public: (01)10846835002416(17)280211(10)31570818M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090898
• 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): 06/23/2025

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 Catalogue Number: BD710DF282RTS
• Device Lot Number: 31570818M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2025
• Initial Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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; FARAPULSE SYSTEM
• Patient Sex: Unknown