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

Catalog Number	BNI35BDH
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient underwent a paroxysmal supraventricular tachycardia (psvt) ablation and the patient experienced cardiac tamponade that required pericardiocentesis.During the procedure, when the physician was looking for target site, cardiac tamponade was found to have occurred.After cardiac tamponade was found to have occurred, it was confirmed whether pericardial effusion was accumulated by echocardiography, and pericardial drainage was performed.After that, blood pressure restored to around 100-110.The patient returned to room with electrocardiogram monitor on.Patient required extended hospitalization.The physician commented after the procedure that there was no causal relationship with the product.Ablation was performed prior to noting the effusion.The effusion occurred after psvt was ablated and recurrence was confirmed, when the thermocool® sf nav bi-directional catheter was re-inserted.No error messages observed on biosense webster equipment during the procedure.The physician's opinion on the cause of the adverse event was the procedure.Transseptal puncture was performed.No evidence of steam pop.Patient has improved.
Additional Manufacturer Narrative
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 number lot 30998496l and no internal actions 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.Manufacturer's reference number:.

• 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: 19620443
• Report Number: 2029046-2024-02109
• Device Sequence Number: 17750939
• Product Code: LPB
• UDI-Device Identifier: 10846835003154
• UDI-Public: 10846835003154
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/26/2024

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 Expiration Date: 02/20/2026
• Device Catalogue Number: BNI35BDH
• Device Lot Number: 30998496L
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2023
• 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 NEEDLE.; UNK PUMP.; UNK_CARTO 3.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Female