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

Model Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 09/30/2022

Event Type  Injury  

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® bi-directional navigation catheter.The patient suffered cardiac tamponade and perforation.It was reported by the clinical account specialist, that a pericardial effusion was found 2hrs after the case was completed and during post-op.They completed ice (intracardiac echocardiography) imaging before and after the case, and no abnormalities were seen.The bwi representative was notified today of the issue, and they tapped it.The patient was in stable condition.It was confirmed that the day the adverse event occurred was on (b)(6) 2022.The adverse event occurred post use of bwi products.The physician¿s opinion on the cause of this adverse event is the procedure and patient condition.The kind of intervention provided was pericardiocentesis.The outcome of the adverse event was improved.Patient was held overnight for observation post procedure.Patient gender was confirmed to be female, age at the time of event or date of birth was unknown.Normal labs pre procedure, act between 300-400 during ablation procedure.Generator make and model with serial number is stockert gmbh, smartablate system, g4c-5534-a.The needle used for the transseptal puncture is a baylis versacross system.Ablation was performed prior to noting the pe or ct.There is no evidence of steam pop.It was unknown the phase the event occurred.The flow setting for the irrigated catheter used in the event is 2 ml/min off ablation, 15 ml/min on ablation.Correct catheter settings were selected on the generator.Pump switching from ¿low¿ to ¿high¿ flow during ablation.No error messages observed on biosense webster equipment during the procedure.The force visualization features used dashboard, vector, visitag.The parameters for stability used for the visitag module was tag size.There was no additional filter used with the visitag.The color option used prospectively was fti.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

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 4.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 reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® 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: 15697570
• MDR Text Key: 302699318
• Report Number: 2029046-2022-02692
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/30/2022

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 Model Number: D134804
• Device Catalogue Number: D134804
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/05/2022
• Initial Date FDA Received: 10/30/2022
• Was Device Evaluated by Manufacturer?: No
• 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 VERSACROSS NEEDLE.; CARTO 3 SYSTEM.; CARTO VISITAG MODULE.; SMARTABLATE GENERATOR.; UNSPECIFIED PUMP.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female