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

Catalog Number D134804

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

Patient Problems Pulmonary Dysfunction (2019); Ventricular Fibrillation (2130); Hypovolemia (2243); Cardiac Perforation (2513)

Event Date 08/11/2023

Event Type  Death  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and the patient developed a cardiac perforation, hemothorax, hypovolaemia ventricular fibrillation, requiring a pericardiocentesis and surgical intervention but ultimately passed away.It was reported that a steam pop was heard while on radiofrequency (rf) near the atrial appendage.Within minutes, anesthesia reported severe hypotension.A pericardial effusion was diagnosed via intracardiac echocardiogram (ice) catheter after the patient's pressure dropped.The patient¿s blood pressure continued to worsen.Decision was made between electrophysiology (ep) and interventional cardiologist to perform pericardiocentesis and 75ml of blood like fluid was removed with no improvement to the patient.Cardiothoracic (ct) surg was consulted.Despite multiple pressors, no improvement in patient¿s blood pressure.An impella device was placed with slight improvement.Left coronary angiogram performed and was unremarkable.Right femoral angiogram/venogram and left femoral venogram were performed and were all unremarkable.Decision was made to obtain a computed tomography (ct) and it showed massive right sided hemothorax.Patient was brought to the operating room (or) and ct finding was confirmed.The patient had a perforation in the anterior corina of the left pulmonary veins, consistent with steam pop.At some point after repair of the perforation, the patient went into ventricular fibrillation and unfortunately was not able to be resuscitated.The patient had a history of mitral valve (mv) repair.In physician¿s opinion, the cause of death was cardiac perforation from steam pop, that led to hemothorax and significant hypovolemia.Force visualization features used were dashboard , vector and visitag.Visitag module was used with parameters for stability of 3/3, fot 3/25, 3mm tag.Tag index was used.Transseptal puncture was performed with a merit heartspan fnd-019-02.Prior to noting the pericardial effusion, ablation was performed.There was evidence of steam pop.The event occurred during the ablation phase.Irrrigated catheter was used in the event, the flow setting was 15ml/min.Smartablate generator parameter was power mode.Temp cut off 36c.Temperature, impedance, and power used was , 50w, 120ohms, 30 degrees.The length (minutes and seconds) of the ablation cycle when the pop was observed at the same tip position was 18secs.No errors reported by the biosense webster systems.

Manufacturer Narrative

On 11-sep-2023, the product investigation was completed as the complaint device was not returned.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.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: 17712718
• MDR Text Key: 322986472
• Report Number: 2029046-2023-02036
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/28/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: D134804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 09/08/2023
• Supplement Dates Manufacturer Received: 09/11/2023
• Supplement Dates FDA Received: 09/28/2023
• 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: IMPELLA DEVICE; MERIT HEARTSPAN FND-019-02; UNK_CARTO 3; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention; Death; Life Threatening
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 68 KG