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

Catalog Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Fistula (1862); Cardiac Tamponade (2226)

Event Date 01/23/2024

Event Type  Death  

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced esophageal fistula, pericardial effusion and stroke.The patient did not wake up after the stroke and passed away.It was reported a patient underwent atrial fibrillation ablation on (b)(6) 2023.This ablation consisted of isolating the pulmonary veins with monitoring of the esophageal temperature.The patient presented to the emergency room on (b)(6) 2024 with persistent chest pain.A pericardial effusion secondary to a pericardium/esophagus fistula is noted.Intervention is carried out to drain this effusion.During this hospitalization the patient suffered a stroke.The patient is then treated surgically for 3 esophageal clips (treatment of pericardium/esophagus fistula).Patient is sedated and intubated at the time of this declaration.Additional information was later received indicating the physician's opinion on the cause of the adverse event is that it was procedure related.The patient worsened and did not wake up due to stroke sequelae.Patient passed away.Transseptal puncture was performed.There was no evidence of any steam pop.No error messages observed on the biosense webster equipment during the procedure.Temperature monitoring in the esophagus was used.Esophageal injury was confirmed with gastroscopy.No evidence of char/thrombus/clot during the procedure.

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.The manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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.Note: the date of death has not been provided.As such, field b2.Date of death has been populated with (b)(6) 2024 as a best estimated date.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

On 26-feb-2024, additional information was received confirming the date of death was (b)(6)2024.The physician¿s opinion on the cause of death is ¿stroke¿.After esophageal surgery patient did not wake up; there was no neurological activity.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® 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: 18748553
• MDR Text Key: 335881935
• Report Number: 2029046-2024-00563
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: HEARTSPAN FND01901 TRANSSEPTAL NEEDLE; LASSO NAV 2515,22P SPLITHANDLE; SMARTABLATE GENERATOR KIT-WW; UNKNOWN IRRIGATION PUMP; UNK_CARTO 3
• Patient Outcome(s): Hospitalization; Required Intervention; Death