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

Catalog Number	BN7TCDF4L
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/13/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent an svt (supraventricular tachycardia) ablation with a ez steer¿ nav bi-directional electrophysiology catheter and the patient experienced pericardial effusion that required pericardiocentesis and medication.During an svt case, a pericardial effusion was noticed in the patient.After the physician had gone transseptal with a brk needle, the 4mm navistar¿ bi-directional catheter was then advanced into the left atrium.They had been mapping for about 30 seconds, when it was noticed that the patient's blood pressure was "increasing." the patient's sinus rate was "increasing" as well on the carto¿ 3 and recording system.The physician did try a different access point when attempting to gain transseptal access, prior to crossing the septum.The pericardial effusion was confirmed via echo (echocardiography), and the pericardial effusion was confirmed and located behind the left atrium.The medical intervention provided was a pericardiocentesis/medication, and it is unknown how much fluid was removed.Protamine and atropine was administered to the patient.The patient was reported to be stable.Physician believes perforation through the heart could have occurred during transeptal with brk needle but is unsure.The patient received extended hospitalization/monitorization after the case.The outcome was improved and the patient received the necessary treatment and recovered.Procedural act (activated clotting time) was unknown.One catheter exchange was performed.Only one transeptal puncture site was done.However, the doctor thinks a second site could have accidentally been punctured with the brk needle.No ablations were performed during this procedure.
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 31583033m 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¿ NAV 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22137690
• Report Number: 2029046-2025-01808
• Device Sequence Number: 15491270
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: (01)10846835002997(17)280317(10)31583033M
• 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
• Report Date (Section B): 06/03/2025

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: BN7TCDF4L
• Device Lot Number: 31583033M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/18/2025
• 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: 6FR CS,D,10 POLE,12 PIN,AUTOID; BRK NEEDLE; CARTO¿ 3 SYSTEM; SMARTABLATE® GENERATOR
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 13 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White