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	10/07/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an (b)(6) female patient ((b)(6)) underwent an atrial fibrillation (afib) ablation procedure with a ez steer¿ thermocool® nav bi-directional catheter and the patient suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.Pericardial effusion was detected during treatment, during use of biosense webster products, and treatment was discontinued.Cardiac tamponade was diagnosed and drainage was performed, but hemostasis could not be achieved, so thoracotomy was performed.The physician commented that it may be due to steam pop.The operation was successfully completed and the patient was resting.The physician commented that since there was a hole in the site different from the site where it noticed the steam pop, it was suspected to be due to excessive ablation at a different site from the steam pop site.Additional information was received which indicated the physician¿s opinion on the cause of this adverse event is that it was procedure related.Drainage and thoracotomy were performed for intervention.Patient outcome from the adverse event was reported as improved.Prior to noting the cardiac tamponade (ct) ablation had already performed.No error messages observed on biosense webster equipment during the procedure.
Additional Manufacturer Narrative
Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30594523m number, and no internal action related to the complaint was found during the review.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(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
• MDR Report Key: 12741534
• Report Number: 2029046-2021-01871
• Device Sequence Number: 20079982
• 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: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/02/2021

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: 07/11/2024
• Device Model Number: BNI75TCDFH
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: 30594523M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Initial Report FDA Received Date: 11/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ACUNAV 8F-90; DEF 7F 20MM DIA 20P CARTO 3; EZ STEER THERMOCOOL NAVIGATION
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 82 YR
• Patient Weight: 45