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 07/13/2023

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.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.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 an idiopathic ventricular tachycardia (idvt) ¿ asc ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac perforation and tamponade requiring a surgical intervention and prolonged hospitalization.It was reported that the patient had a perforation with pericardial effusion and tamponade.They reported that they saw a small trace pericardial effusion using intracardiac echocardiography (ice) following ablation of the left ventricle.They continued with an alcohol ablation and following the alcohol ablation, the pericardial effusion increased in size significantly.The pericardial effusion was confirmed with ice.They attempted to perform a pericardiocentesis but that they were unable to access it due to adhesions around the right ventricle.The patient was taken to surgery to open the patient up and drain the pericardial effusion.They reported that the left ventricle did not have a lot of movement left in it anymore and that the patient was on ecmo.The caller reported that it was unknown if the patient was in stable condition.The physician stated that it could have been a left ventricle perforation from where they burned but that the reason for the injury was indeterminate.The adverse event was discovered after use of biosense webster products.Physician¿s opinion on the cause of this adverse event is that it was the procedure.The patient¿s outcome from the adverse event was reported as worsened, patient survived but was on ecmo.Patient had little left ventricle squeeze left post operative.Patient required extended hospitalization because of the adverse events due to condition.A smartablate generator was used in this case and an irrigated catheter was used with the flow setting at 2 base 8/15 low and high.All force visualization features were used.Visitag module was used, parameters for stability was range: 2mm, time: 3seconds, force over time (fot) 5 grams 40% and 3mm tags.Additional filter used with the visitag was 40% 5g force.Color options used prospectively was surpoint tag index.Transseptal puncture performed with a st jude brk.No evidence of steam pop.The event occurred post ablation phase after performing alcohol ablation.Prior to noting the pe or ct, ablation had already been performed.

• 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: 17495682
• MDR Text Key: 320763151
• Report Number: 2029046-2023-01745
• 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: 08/09/2023

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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/13/2023
• Initial Date FDA Received: 08/09/2023
• 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: CARTO 3 SYSTEM; SMARTABLATE GENERATOR SPARE-US; ST JUDE BRK NEEDLE
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening
• Patient Age: 75 YR
• Patient Sex: Male