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

Catalog Number	BD710DF282CT
Medical Device Problem Codes	Signal Artifact/Noise (1036); Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a webster cs catheter and observed an insulation break at the tip of the catheter and metal wires were exposed.The distal two electrodes of the catheter appeared black on the carto 3 system and there was noise from those electrodes on both the carto 3 system and the recording system.The catheter was removed from the body and they noticed that there was an insulation break at the tip of the catheter and metal wires were exposed.The catheter was replaced and the issue was resolved.The procedure was continued.There was no patient consequence reported.The catheter was brand new from biosense webster, inc.Box packaging.The distal two electrodes of the catheter appeared black on the carto 3 system and there was noise from those electrodes was assessed as non mdr.The risk to the patient was low.The insulation break at the tip of the catheter and metal wires were exposed issue was assessed as mdr reportable.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 02-sep-2025.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a webster cs catheter.The distal two electrodes of the catheter appeared black on the carto 3 system and there was noise from those electrodes on both the carto 3 system and the recording system.The catheter was removed from the body and they noticed that there was an insultation break at the tip of the catheter and metal wires were exposed.The catheter was replaced and the issue was resolved.The procedure was continued.There was no patient consequence reported.The device evaluation was completed on 09-sep-2025.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 inspection revealed no damage or anomalies on the device.No damage or internal components exposed were observed; however, the adhesive window located in the tip of the device its a normal condition.An electrical test was performed, and no electrical issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The noise and broken tip issues 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 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.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: WEBSTER CS
• 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: 22955321
• Report Number: 2029046-2025-02974
• Device Sequence Number: 13159562
• Product Code: DRF
• UDI-Device Identifier: 10846835002409
• UDI-Public: (01)10846835002409(17)280619(10)31681715M
• 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,Followup
• Report Date (Section B): 10/03/2025

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: BD710DF282CT
• Device Lot Number: 31681715M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 09/09/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• 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 RECORDING SYSTEM.; UNK_CARTO 3.; UNK_NGEN RF GENERATOR.
• Patient Sex: Unknown