MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ THERMOCOOL® BI-DIRECTIONAL CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	BNI75TCDFH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	12/15/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient underwent a cardiac ablation procedure and patient experienced cardiac tamponade treated with a pericardiocentesis.Rf needle was not used for transseptal puncture.Ablation was performed.One hour after the procedure was started and during the ablation, impedance increased mid-ablation.The ablation was immediately stopped, but the blood pressure decreased.No steam pops have been confirmed.Pericardial drainage was performed and blood pressure was stabilized.The patient was conscious, but returned to the icu for monitoring.The patient's condition improved at this point.No error messages on equipment during procedure.The physician's opinion on the cause of the adverse event is the procedure.The physician mentioned that right ventricular outflow tract, the site of ablation, is normally indented, but the patient's right ventricular outflow tract was appeared even more indented than others on the computed tomography (ct) scan.The patient's breath was deep, so the tip of the catheter may have been stuck in the indented hollow during ablation, resulting in cardiac tamponade.The patient became stable and moved to general ward on the day after the procedure.Patient fully recovered.
Additional Manufacturer Narrative
E1 initial reporter phone: (b)(6).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31161468m and no internal action related to the complaint was found during the review.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 reference number: (b)(4).

• Brand Name: EZ STEER¿ THERMOCOOL® BI-DIRECTIONAL CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 18489530
• Report Number: 2029046-2024-00142
• Device Sequence Number: 6991869
• Product Code: OAD
• UDI-Device Identifier: 10846835003338
• UDI-Public: 10846835003338
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P030031
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/10/2024

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: BNI75TCDFH
• Device Lot Number: 31161468M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/15/2023
• Initial Report FDA Received Date: 01/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/11/2023
• 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, JAPAN; UNK_CARTO 3; UNK_NGEN PUMP; UNSPECIFIED RF NEEDLE
• Outcome Attributed to Adverse Event: Required Intervention; Life Threatening; Hospitalization
• Patient Sex: Female