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

Catalog Number SMART TOUCH BIDIRECTIONAL SF

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 07/14/2023

Event Type  Injury  

Manufacturer Narrative

Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because 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.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 ablation that included thermocool® smart touch® sf bi-directional navigation catheter.The patient experienced cardiac perforation / cardiac tamponade that required pericardiocentesis.During the procedure, a pericardial effusion from a possible perforation during transseptal access was noticed.Following a cti ablation and shortly after performing a transseptal puncture, the physician noticed that the patient's blood pressure dropped to unsafe levels.The pericardial effusion was confirmed with intracardiac echocardiography (ice).The medical intervention performed was that they removed the blood from the epicardial space and added some fluid to get the patient's blood pressure back up.It was unknown how much blood was removed from the patient.The patient was in stable condition.The procedure was aborted.Did not have any information about the ablation catheter.Additional information was received on 17-jul-2023.An email was received from the caller that stated that he was informed by the physician that the patient is doing well and that the patient is projected to receive ablation in a couple of months.Additional information was received on 17-jul-2023.Outcome of the adverse event was fully recovered.Transseptal puncture was done with baylis versacross needle.A cti ablation was performed in the right atrium before the cardiac tamponade.No evidence of steam pop.The event occurred during the transseptal phase.Flow settings for irrigated catheter was smarttouch sf unmodified settings.Correct catheter settings were selected on the generator.Pump switched from ¿low¿ to ¿high¿ flow during ablation.No error messages observed on biosense webster equipment during the procedure.Visualization features that were used: graph, dashboard, vector, visitag.Parameters for stability used: 3mm, 3s, 25%, 3mm size.Additional filters used with the visitag: fti.

• 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: 17504880
• MDR Text Key: 321045241
• Report Number: 2029046-2023-01755
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 08/10/2023

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: SMART TOUCH BIDIRECTIONAL SF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/14/2023
• Initial Date FDA Received: 08/10/2023
• 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: NON BWI-BAYLIS VERSACROSS NEEDLE; UNK GENERATOR; UNK PUMP; UNK_CARTO 3
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Female