MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number	NI75TCJH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	08/02/2022
Type of Reportable Event	Serious Injury
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 4.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).
Event or Problem Description
It was reported that a 73-year-old female patient (59kg) underwent an atrial fibrillation (afib) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter.The patient suffered a cardiac tamponade that required a pericardiocentesis.There was a steam pop.It was reported that a steam pop occurred in the left atrial appendage during ablation.They were ablating at 45 watts when the steam pop occurred.The steam pop occurred on the first or second ablation.There was no visible char on the catheter.The flow rate of the catheter was appropriate and the catheter was flushed prior to ablation.The temperature readings displayed on the carto 3 system on and off ablation were normal.Additional information was received.The patient ended up with cardiac tamponade and a pericardiocentesis was done.There were 200 ccs of fluid was removed and the patient was stable.The patient stayed overnight with the drain in place.The drain was removed earlier today and the patient did not require any surgical repair.The physician¿s opinion on the cause of this adverse event was a bwi product malfunction.The patient outcome of the adverse event was fully recovered (no residual effects).The patient required extended hospitalization because of the adverse event, intensive care unit (icu) stay for observation until drain removed.A transseptal puncture was performed with a baylis nrg transseptal needle; standard curve c0; nrg-e-hf-71-c0.The irrigated catheter flow setting was15ml.The correct catheter settings were selected on the generator and the pump was switching from low to high flow during ablation.No errors on biosense webster, inc.Equipment.
Additional Manufacturer Narrative
The device evaluation was completed on 31-aug-2022.It was reported that a 73-year-old female patient (59kg) underwent an atrial fibrillation (afib) ablation procedure with a navi-star¿ thermo-cool¿ electrophysiology catheter.The patient suffered a cardiac tamponade that required a pericardiocentesis.There was a steam pop.The product was returned to biosense webster for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, and temperature features were tested, and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The ifu (instruction for use) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.As part of biosensor webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 25-aug-2022.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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: NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-7981
• MDR Report Key: 15290835
• Report Number: 2029046-2022-01973
• Device Sequence Number: 2407149
• Product Code: OAD
• UDI-Device Identifier: 10846835000573
• UDI-Public: 10846835000573
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2022

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: 09/14/2023
• Device Model Number: NI75TCJH
• Device Catalogue Number: NI75TCJH
• Device Lot Number: 30433984M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2022
• Supplement Date Received by Manufacturer: 08/25/2022; 08/31/2022
• Initial Report FDA Received Date: 08/25/2022
• Supplement Report FDA Received Date: 08/29/2022; 09/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/15/2020
• 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- BAYLIS NRG TRANSSEPTAL NEEDLE; SMARTABLATE GENERATOR KIT-US; UNKNOWN BRAND PUMP; UNK_CARTO 3
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 59 KG