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

Catalog Number BNI35DFCT

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); Cardiac Perforation (2513)

Event Date 09/29/2023

Event Type  Injury  

Event Description

It was reported a patient underwent a idiopathic vt cardiac ablation procedure utilizing a thermocool® sf nav bi-directional catheter and the patient experienced cardiac perforation and cardiac hematoma and required hospitalization for further evaluation.During the procedure while utilizing the ablation catheter in the left ventricle, the catheter perforated into the right atrium discovered by utilizing the soundstar catheter.The intracardiac echo showed a hematoma within the heart and the transesophageal echo confirmed the hematoma.The cardiac surgery team arrived in the room and, after approximately 20 minutes, the hematoma was evaluated and did not appear to be getting larger.The patient remained stable and was taken to computed tomography (ct) to complete a scan.Anticoagulants were stopped and no further intervention was performed beyond discontinuation of the procedure and subsequent ct scan.Physician's opinion on cause of the event is patient condition.Patient has ebstein congenital heart defect anomaly and this procedure and this would be the 7th cardiac procedure besides other relevant medical history.Correct settings selected on devices, and no error messages on equipment during procedure.No evidence of steam pop.

Manufacturer Narrative

On (b)(6) 2023, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported a patient underwent a idiopathic vt cardiac ablation procedure utilizing a thermocool® sf nav bi-directional catheter and the patient experienced cardiac perforation and cardiac hematoma and required hospitalization for further evaluation.During the procedure while utilizing the ablation catheter in the left ventricle, the catheter perforated into the right atrium discovered by utilizing the soundstar catheter.The intracardiac echo showed a hematoma within the heart and the transesophageal echo confirmed the hematoma.The cardiac surgery team arrived in the room and, after approximately 20 minutes, the hematoma was evaluated and did not appear to be getting larger.The patient remained stable and was taken to computed tomography (ct) to complete a scan.Anticoagulants were stopped and no further intervention was performed beyond discontinuation of the procedure and subsequent ct scan.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.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.Physician's opinion on cause of the event is patient condition.As part of biosense 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 ref.#(b)(4).

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Type of Device: 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: 17998866
• MDR Text Key: 326447530
• Report Number: 2029046-2023-02415
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835003208
• UDI-Public: 10846835003208
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BNI35DFCT
• Device Lot Number: 30987939L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN GENERATOR; UNKNOWN PUMP; UNKNOWN TRANSESOPHAGEAL ECHO; UNK_SOUNDSTAR
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Sex: Female