MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	BNI35FJCT
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	03/16/2023
Type of Reportable Event	Death
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® sf nav bi-directional catheter and suffered cardiac tamponade (ct) requiring pericardiocentesis and prolonged hospitalization but ultimately passed away.It was reported that the patient suffered a pericardial effusion (pe).They stated that after cryo ablation there was some rf ablation was performed, and the patient spontaneously converted from atrial fibrillation to sinus after the rf ablation.The pressure dropped and when the physician looked via intracardiac echocardiography (ice) they observed a pericardial effusion.The location of the effusion was unknown.A pericardiocentesis was performed and 630 ml was removed.They confirmed that the drainage tube was left in place.The patient's prognosis was stabilized and has improved.The patient will be admitted to the intensive care unit for overnight observation.The adverse event occurred on (b)(6) 2023.It was discovered post use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that the physician suspected a steam pop.Intervention provided was a pericardiocentesis and cardiovascular operating room (cvor) surgical intervention.Patient required extended hospitalization because of the adverse event.The patient expired.Transseptal puncture was performed with an abbott brk xs.Prior to noting the pe or ct, ablation was performed.There was no evidence of steam pop but the physician suspected this as the cause in retrospect.The event occurred during the ablation phase.Irrigation catheter was used with flow mode (8 low/15 high).The date of death was (b)(6) 2023.A pericardial effusion occurred in the case and 680 ml was drained (previously reported as 630 ml) in the room.The patient was brought to recovery where they went asystole and then recovered.1.5l was pulled from the pericardial drain in recovery before the patient was brought to cvor.They were told the patient made it out of surgery but then heard the next day that the patient passed.Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.No error messages observed on biosense webster equipment during the procedure.
Additional Manufacturer Narrative
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
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 30974142l number, and no internal action related to the complaint was found during the review.Additionally, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.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: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 16729160
• Report Number: 2029046-2023-00803
• Device Sequence Number: 20514934
• Product Code: LPB
• UDI-Device Identifier: 10846835003260
• UDI-Public: 10846835003260
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S025
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2023

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: 01/12/2026
• Device Model Number: BNI35FJCT
• Device Catalogue Number: BNI35FJCT
• Device Lot Number: 30974142L
• 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: 03/16/2023
• Supplement Date Received by Manufacturer: 06/17/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 07/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2023
• 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: 6FR DEFL,4P,D,SD,5MM,12PR; ACUNAV ¿ STRYKER REPROCESSED CATHETER; UNK ABBOTT BRK XS; UNK BRAND GENERATOR; WEBSTER CS - STRYKER REPROCESSED CATHETER
• Outcome Attributed to Adverse Event: Death; Hospitalization; Required Intervention
• Patient Sex: Female