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

Catalog Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 07/20/2023

Event Type  Injury  

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.A manufacturing record evaluation (mre) cannot be conducted because 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent atrial fibrillation ablation procedure that included thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac perforation that required pericardiocentesis and surgical intervention and prolonged hospitalization.It was reported by the caller, the bwi representative, that during an afib case while ablating on the pulmonary vein, a steam pop was heard by the physician who quickly checked on intracardiac echocardiography (ice) and found that a perforation of the left pulmonary vein was noticed.The caller stated that the case stopped and the heart tapped (pericardiocentesis) was done.Two units of blood were taken out of the pericardial sack.They moved to open the chest of the patient to address the perforation on the left pulmonary vein.The caller reported the patient was placed in comfort care (end of life care) at this time.The caller was not able to gather information on the catheter since when the emergency happened everything was put in the trash to make room for the ecmo equipment.The physician's opinion on the cause of the adverse event is that it was patient condition and procedure related.The patient¿s outcome worsened.Patient required extended hospitalization and placed on comfort care.Transseptal puncture was performed with baylis nrg needle.The irrigated catheter flow setting was: low flow 2 ml/min, for low power abl 8 ml/min, high power 15 ml/min.Correct catheter settings were selected on the smartablate generator and the pump was switching from "low" to "high" flow during ablation.No error messages observed on bwi equipment during the procedure.Force visualization features used: graph, dashboard, vector, visitag.Parameters for stability used were 2.3 mm range, 3 sec minimum, 3 mm radius, 25% over time with 3g minimum.No additional filter used with the visitag.Color options used included colored based on impedence drop 5-10 ohms.

• 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: 17563734
• MDR Text Key: 321323249
• Report Number: 2029046-2023-01797
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: Physician
• Type of Report: Initial
• Report Date: 08/17/2023

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: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/17/2023
• 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: BAYLIS NRG NEEDLE; CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-US; UNKNOWN PUMP
• Patient Outcome(s): Hospitalization; Required Intervention