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

Model Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 09/28/2020

Event Type  Injury  

Manufacturer Narrative

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 was performed for the finished device 30412912l number, and no internal action related to the complaint was found during the review.(b)(4).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 male patient (100kg) underwent a cardiac ablation procedure for paroxysmal atrial fibrillation with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.During the ablation phase, a perforation to the roof of the left atrium (la) right beside the right superior vein occurred with the thermocool® smart touch® sf bi-directional navigation catheter.Reminder of the procedure was aborted.Pericardiocentesis was performed to drain the fluid from the pericardial space.The patient was sent to the operating room for surgical intervention to close the perforation.The patient was expected to stay an additional day at least.Patient had fully recovered from the issue.The physician believed the issue occurred because of the way he used the equipment.Transseptal puncture was performed with a cook needle.There was no evidence of steam pop during the ablation.The catheter irrigation was set at 15ml/ minute flow rate at 45 watts.The force visualization features used included graph, dashboard, vector and visitag.At the time of perforation, a hi force alert came up and the catheter visually moved outside the carto generated heart geometry.The parameters for stability used with the visitag module were 2ml range, 3 seconds, force over time (fot) of 25%, and tag size of 2mm.Fti was used as coloring option.No other visitag filters were used.The procedure delayed by 60 minutes.The patient did not get any ssi (surgical side infection) due to the delay experienced.

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10738292
• MDR Text Key: 214384502
• Report Number: 2029046-2020-01563
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/04/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30412912L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2020
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Weight: 100