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

Catalog Number D134805

Device Problems Insufficient Cooling (1130); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Myocardial Infarction (1969)

Event Date 11/20/2023

Event Type  Death  

Event Description

It was reported that a patient underwent a cardiac ablation and the patient experienced st elevations / cardiac arrest that required coronary angiogram and percutaneous cardiopulmonary support (pcps), but ultimately the patient passed away.First (during preop), it was reported that the smartablate tubing set had cloudiness within the tube that could not be distinguished from bubbles.No bubble recognition activated on the pump side.The issue was immediately confirmed after priming the tubing.The medical team replaced the tubing and proceeded with the procedure.Then, when ablation was conducted, temperature rose instantly and ablation was stopped.The issue was resolved by replacing the smart touch sf catheter to another new one.Temperature cut off value was 45c, approximate temperature at the time of failure was 46c.The cutoff value was caught and ablation was stopped.The ablation was stopped automatically--no ablation was conducted above the temperature cut off value.While ablating the anterior wall of the left atrial septum, st elevation was confirmed.Cardiac arrest occurred when cag (coronary angiography) was about to be performed.Pcps was used and the patient's condition was stabilized, so the patient left the room.The physician thought it was probably spasms, and their opinion was that the adverse event was not related to the ablation or any corresponding ablation effect.No abnormalities were observed prior to or during use of the product.Ultimately, the patient died.The patient was weaned from pcps on (b)(6) 2023 and his condition stabilized.However, the patient passed away on (b)(6) 2023.The cause of death was diagnosed as acute myocardial infarction.Relevant medical history includes diabetes, stents, heart failure.

Manufacturer Narrative

Initial reporter phone: (b)(6).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 reference number:(b)(4).

Manufacturer Narrative

On 8-jan-2024, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent a cardiac ablation and the patient experienced st elevations / cardiac arrest that required coronary angiogram and percutaneous cardiopulmonary support (pcps), but ultimately the patient passed away.First (during preop), it was reported that the smartablate tubing set had cloudiness within the tube that could not be distinguished from bubbles.No bubble recognition activated on the pump side.The issue was immediately confirmed after priming the tubing.The medical team replaced the tubing and proceeded with the procedure.Then, when ablation was conducted, temperature rose instantly and ablation was stopped.The issue was resolved by replacing the smart touch sf catheter to another new one.Temperature cut off value was 45c, approximate temperature at the time of failure was 46c.The cutoff value was caught and ablation was stopped.The ablation was stopped automatically--no ablation was conducted above the temperature cut off value.While ablating the anterior wall of the left atrial septum, st elevation was confirmed.Cardiac arrest occurred when cag (coronary angiography) was about to be performed.Pcps was used and the patient's condition was stabilized, so the patient left the room.The physician thought it was probably spasms, and their opinion was that the adverse event was not related to the ablation or any corresponding ablation effect.No abnormalities were observed prior to or during use of the product.Ultimately, the patient died.The patient was weaned from pcps on (b)(6) 2023 and his condition stabilized.However, the patient passed away on (b)(6) 2023.The cause of death was diagnosed as acute myocardial infarction.Relevant medical history includes diabetes, stents, heart failure.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.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.The temperature values were found within the specifications.A manufacturing record evaluation was performed for the finished device 31100061l number, and no internal actions related to the reported complaint condition were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, 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 instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.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 reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION 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: 18338505
• MDR Text Key: 330658568
• Report Number: 2029046-2023-02983
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31100061L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2023
• 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: CARTO 3 SYSTEM WITH VISITAG.; SMARTABLATE GENERATOR.; SMARTABLATE TUBING.
• Patient Outcome(s): Required Intervention; Death; Life Threatening
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 61 KG