MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER NAV; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Catalog Number	BN7TCDF4L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	06/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device number lot 31583036m and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported during atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a ez steer nav catheter and the patient experienced heart block with heart rate of 40-45 beats per minute treated with pacemaker implant and prolonged hospitalization.During an avnrt, the physician completed a round of ablations outside the ostium of the coronary sinus.Ablations started at 25 watts with a ez steer nav and increased to 30watts.There was a junctional response indicating that the radiofrequency rf was applied in the correct location.Post ablation testing indicated that the patient required more therapy.Ablation was resumed at 30 watts.Shortly after the start of ablation the patient had a run of atrial tachycardia followed by non-conducting ventricular beats seen on the surface and intracardiac signals.Ablation was terminated and the cardiac signals showed the patient to be in a 2:1 heart block with a ventricular rate of 40 to 45 beats per minute.The patient was paced via a quad catheter in the right ventricle for about 15 minutes to see if normal conduction would return.After 15 minutes the ventricular pacing stopped, and it was noted that the patient was still in heart block.The patient was prepped for permanent pacemaker implantation.The patient was stable throughout the procedure and was currently undergoing the pacemaker implantation.The last known patient status was stable.The physician¿s opinion on the cause of this adverse event was possible extension of the his bundle near cs ostium.The intervention provided was attempted pacing of the atrium, and waiting for recovery before deciding a pacemaker was needed.The outcome of the adverse event was that the patient was okay after the pacemaker was installed.The patient required an additional extended hospitalization because of needed for recovery after pacemaker installed due to the time of day.

• Brand Name: EZ STEER NAV
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• 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: 22503668
• Report Number: 2029046-2025-02325
• Device Sequence Number: 15639842
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: (01)10846835002997(17)280311(10)31583036M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P990025/S12
• 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?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: BN7TCDF4L
• Device Lot Number: 31583036M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2025
• Initial Report FDA Received Date: 07/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/12/2025
• 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: ABBOTT AGILIS SHEATH; CARTO 3; SMARTABLATE GENERATOR; WEBSTER CS CATHETER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White