MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER ® CS CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Catalog Number	BD710DF282CT
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation with a webster ® cs catheter with ez steer® thechnology and auto id and the patient experienced heart block that required pacemaker insertion.Av (atrioventricular) heart block was discovered once the av sequential pacing (pacing via cs catheter and the his catheter in the ventricle) was turned off.The patient was being sequentially paced, and on nitro while pfa (pulse field ablation) lesions were applied on the anterior wall of the left atrium when the heart block occurred.Isuprel was administered, but the normal sinus rhythm did not return.Patient was paced from the catheter while a permanent pacemaker was inserted.Patient was stable.
Additional Manufacturer Narrative
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
On 14-mar-2025, bwi received additional information regarding the event.The physician's opinion on the cause of the adverse event is that he thinks he bumped the av (atrioventricular) node with the farawave catheter.However, at the end of the day conduction came back to the doctor thinks that he bumped it.There were no malfunctions with the cs (coronary sinus) catheter.The physician does not believe the cs catheter contributed to the av block.Intervention includes dual chamber pacing was done until the end of the procedure and pacemaker was inserted.Patient fully recovered.Additionally, on 19-mar-2025, the product investigation was completed as the complaint device was confirmed to be discarded.An analysis of the product could not be performed since a physical sample was not received for evaluation.An evaluation of the manufacturing record could not be performed as the required product identification number was not provided to complete the evaluation.As part of our company quality system process, all devices are manufactured, inspected, and distributed 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 CATHETER WITH EZ STEER® THECHNOLOGY AND AUTO ID
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21540041
• Report Number: 2029046-2025-00704
• Device Sequence Number: 8050429
• Product Code: DRF
• UDI-Device Identifier: 10846835002409
• UDI-Public: 10846835002409
• 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): 04/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: BD710DF282CT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 03/06/2025
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 GENERATOR
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening
• Patient Sex: Unknown