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

Model Number	BNI75TCDFH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/25/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a ventricular tachycardia ablation procedure with a ez steer¿ thermocool® nav bi-directional catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that after completion of the procedure, poor cardiac shadowing was showed by fluoroscopy and pericardial effusion volume was confirmed by echocardiography.Blood pressure dropped to the 60s, but the patient was clearly conscious.Timing was immediately after completion of the procedure, by the echocardiography.Pericardial drainage was performed, blood pressure was stabilized, and the patient returned to intensive care unit (icu).Atrial septal puncture was performed.Septal puncture was performed with fukuda denshi rf needle and ablation was conducted in the left ventricle.Ablation was performed before the cardiac tamponade was detected.Steam pop was not confirmed.Irrigation catheter was used, the flow rate setting was pre 1 sec., post 5 sec.Setting, irrigation 17ml, high flow 30ml, no change after the pericardial drainage, the blood pressure returned to the 100s and stabilized, and consciousness was clear throughout the procedure.The patient was followed up in icu.No contact force monitoring because a catheter without contact force was used.The ablation was performed while checking impedance elevation and observation by fluoroscopy.Physician¿s judgment on the health hazard was non-serious (moderate/minor).Coloring setting of visitag: total time.There were no abnormalities observed prior to and while using product.Additional information was received.It was discovered post use of biosense webster products.Outcome of the adverse event was improved.The event occurred after the ablation procedure completed.Irrigated catheter was used in the event, the flow setting was pre rf time: 1sec, post rf time 5sec, during ablation: up to 30w: 17ml/min, over 31w: 30ml/min.No error message observed.Color options used prospectively was total time.
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.Investigation is in progress, once completed a supplemental will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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
The investigation was completed on 30-jun-2023.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 30913749m number, and no internal action related to the complaint was found during the review.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® NAV 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: 17188089
• Report Number: 2029046-2023-01368
• Device Sequence Number: 5806540
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2023

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 Expiration Date: 12/13/2025
• Device Model Number: BNI75TCDFH
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: 30913749M
• 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: 05/25/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/14/2022
• 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: NON BWI-FUKUDA DENSHI RF NEEDLE; OCTA,LNG,48P,3-3-3-3-3,D-CURVE; SOUNDSTAR ECO GE 8F CATHETER; UNK_CARTO 3
• Outcome Attributed to Adverse Event: Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female