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

Model Number D134805

Device Problems Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198); Material Protrusion/Extrusion (2979); Output Problem (3005)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 05/11/2021

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with 2 thermocool® smart touch® sf bi-directional navigation catheters and suffered a cardiac tamponade requiring pericardiocentesis.It was reported that the wire on the foot pedal of the smartablate generator was exposed.A foot pedal replacement was requested.It was also reported that the thermocool® sf nav bi-directional catheter shaft was not working as the visualization of the catheter was bad.The catheter cable was replaced and the issue remained.The catheter was replaced and the issue resolved.It was also reported that metal interferences on patches error was shown which led to map shift on the carto 3 system.It was also reported that during the ablation procedure, a pericardial effusion was noticed at 4 hours into the case as the patient became hypotensive.The effusion was confirmed by intracardiac echo (ice).Pericardiocentesis was done to drain 180 cc of fluid from the pericardial space.Patient was reported in stable condition after drainage.Physician relates the cause of the event to the procedure and to the usage of a non-bwi sheath and catheter placement in the great cardiac vein (gcv).There¿s no report of prolonged hospitalization.Patient had fully recovered.Transseptal puncture was not done.There was no evidence of steam pop during the ablation.Instructions for use standards flow settings were met.The correct catheter settings were selected on the generator.The pump was switching from low to high during the ablation.Graph, dashboard, vector and visitag were used as force visualization features.The parameters for stability on the visitag module were 3mm 3sec 25%>3g 2mm tags.No additional filter was used.Fti was used as coloring option.With the information available, the adverse event was conservatively assessed as mdr reportable under both the thermocool® smart touch® sf bi-directional navigation catheters used as it was assumed both were used to ablate; therefore, none of them can be excluded.Should more information become available, it will be reviewed and processed accordingly.Since the event is life threatening and required surgical intervention to prevent permanent impairment of a body function or permanent impairment of a body function, it was to be considered serious and mdr-reportable.The visualization issue was assessed as not mdr reportable.If the catheter was not visualized correctly in the carto 3 system, the user will have to replace the catheter in order to complete the case.The potential risk that it could cause or contribute to a death or serious deterioration in state of health was remote.The map shift issue described was assessed as not mdr reportable.If there¿s a map shift from which the system displays an error message, it would not be considered a system malfunction but the system¿s normal behavior.The metal interference issue was assessed as not mdr reportable.If there¿s metal interference, the most likely consequence would be an intraprocedural delay or cancellation.The potential risk to the patient was remote.The foot pedal issue was assessed as not mdr reportable.The most likely consequence would be an intraprocedural delay or cancellation.The potential risk to the patient was remote.

• 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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11933207
• MDR Text Key: 254265490
• Report Number: 2029046-2021-00862
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/11/2021
• 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
• Patient Outcome(s): Life Threatening; Required Intervention