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

Catalog Number SEE H10.

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226)

Event Date 02/09/2024

Event Type  Death  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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: field d4 catalog should be unk_smart touch bidirectional sf.Note: exact date of death was not provided.It occurred between (b)(6) 2024 thru (b)(6) 2024.As such, field b2.Date of death has been populated as (b)(6) 2024 as the best estimate.Biosense webster manufacturer's reference number (b)(4) has two reports: mfr # 2029046-2024-00728 for product thermocool® smart touch® sf uni-directional navigation catheter.

Event Description

It was reported a patient underwent an atrial fibrillation and typical flutter cardiac ablation procedure with cavotricuspid ishmus (cti) ablation in the end.Two (2) thermocool® smart touch® sf uni-directional navigation catheters were used in the procedure.The patient experienced cardiac tamponade treated with a pericardiocentesis and intensive care afterwards since their heart was very weak.The patient ultimately died.The medical team conducted a pulmonary vein isolation (pvi) and after finishing the procedure the patient's blood pressure was very low and the doctor noticed we had an pericardial punction.During ablation in left atrium (la), approximate 3-4 steam pops occurred.The overall impedance was low during the whole procedure.The medical team checked the neutral electrode, but everything was fine.They changed the catheter, but there one more steam pop occurred.Steam pop during procedure occurred with thermocool smart touch curve.Carto system & smartablate generator showed no errors.Patient was critical the whole procedure and was also very weak in the beginning of the procedure already.The low blood pressure and pe (pericardial effusion) was noticed a few minutes after finishing the procedure.After pericardial punction (pericardiocentesis), approximately 600 ml of blood was drawn, the pericardial effusion was fine.Then the patient's heart got slower until the ventricle stopped pumping and the medical team started with resuscitation.After 6 minutes, the heart started to pump again but the patient had to be intubated because of his critical health status and he was sent to intensive care unit.The patient was very weak because of a bad heart pump as a result of his pre-existing conditions.He was resuscitated several times but the pe was not the issue anymore, as the doctor reported.The doctor said that the patient showed electrical decoupling of the heart and was not able to pump anymore.He died in the weekend in the intensive care station.Physician's opinion on the cause of the event is the patient's condition.The patient was very weak before and during the whole procedure.Unfortunately, the pe made the health status worse at that moment and their condition did not improve even after the pe was removed.The patient's heart got even worse due to the poor ventricular pumping performance.No errors or malfunctions noticed on the bwi devices used.Based on available information, two ablation catheters were used during the procedure, as such both ablation catheters are suspected devices as they both delivered rf energy in direct contact with cardiac tissue.

• 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: 18866607
• MDR Text Key: 337227800
• Report Number: 2029046-2024-00783
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SEE H10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2024
• 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: ACUNAV CATHETER.; HEART SPAN TRANSSEPTAL NEEDLE.; PREFACE 8F SHEATH.; THMCL SMTCH SF UNID, TC, D.; UNK_CARTO 3.; UNK_SMARTABLATE GENERATOR.
• Patient Outcome(s): Life Threatening; Hospitalization; Death; Required Intervention