MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Catalog Number	BD7TCDF4L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Heart Block (4444)
Date of Event	09/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a supraventricular tachycardia (svt)/ atrioventricular nodal reentry tachycardia (avnrt) ablation with a ez steer¿ bi-directional electrophysiology catheter and the patient experienced heart block that required pacemaker insertion.The case was listed as an svt case, after the ep (electrophysiology) study the medical team found that it was an avnrt case so at this point the physician decided he didn¿t want to use carto to map and just took a non-nav catheter and used x-ray.The physician used a non-nav ez steer non-irrigated catheter.The medical team carried out 5 ablations at 40 w successfully.On the 6th ablation the physiologist saw v's with no a's so the doctor stopped ablating.The ablation only lasted 6s with a normal temperature rise and impedance change.The patient then experienced av (atrioventricular) dissociation.At this point, the team waited an hour whilst pacing and the patient then had 2:1 conduction when leaving the lab., the doctor suggested an overnight stay for the patient to monitor him and hope for a full recovery.Intervention included cs (coronary sinus) pacing and extended hospitalization (overnight monitoring).The catheter used for ablation was a non-nav ez steer and all lesions were performed on power control mode at 40 w.The physician's opinion on the cause of the adverse event was the procedure.Carto system wasn¿t used.Patient required a permanent pacemaker.
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot 31369457m 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.Manufacturer's reference number: (b)(4).

• Brand Name: EZ STEER¿ BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20517054
• Report Number: 2029046-2024-03450
• Device Sequence Number: 7765632
• Product Code: LPB
• UDI-Device Identifier: 10846835002515
• UDI-Public: (01)10846835002515(17)270621(10)31369457M
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: P950005/S19
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/23/2024

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: BD7TCDF4L
• Device Lot Number: 31369457M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/22/2024
• 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: NGEN RF GENERATOR KIT.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 27 YR
• Patient Sex: Male