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

Model Number D134702

Device Problems Low impedance (2285); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problems Cardiac Arrest (1762); Cardiac Tamponade (2226)

Event Date 05/02/2022

Event Type  Death  

Event Description

It was reported that an 80-year-old male patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis, cardiac arrest requiring cpr and surgical intervention, and ultimately death.It was reported that the patient suffered a pericardial effusion.A steam pop was noted when ablating below the left atrial appendage, and an effusion was immediately seen on ice (intracardiac echo) imaging, it was approximately 2 cm.A pericardiocentesis was performed, with approximately 5500 ml of fluid removed.The patient then had pea (pulseless electrical activity), cardioversion was performed, and cpr was initiated.Surgical team then arrived, the patient's chest was opened, and the patient was placed on bypass.Surgical team is still working on the patient in the ep lab.The patient expired; the date of death was (b)(6) 2022.In physician¿s opinion, the cause of death was massive loss of blood due to a steam pop at the base of the left atrial appendage.Total loss of blood, while replacing with cell saver and product was 9l.It was also reported that the unipolar ablation signal was "floating".The catheter was exchanged, and the issue was resolved.The procedure was continued.Additionally, there was a "temperature invalid" error displayed on the smartablate generator.The ablation cable was exchanged, and the issue was resolved.The procedure was continued.No replacement requested, as the cable was reprocessed.This adverse event was discovered during ablation.In the physician¿s opinion on the cause of this adverse event is that it was caused by the catheter.The patient did require extended hospitalization because of the adverse event.A transseptal puncture was performed with a heartspan needle.Prior to noting the effusion ablation was performed.There was evidence of steam pop.The steam pop lesion had an average force reading of 12 grams, with an impedance drop of 11 ohms.The event occurred during the ablation phase.An irrigated catheter was used in the event, the flow setting was 8/15ml per ifu (instructions for use).The "temperature invalid" error displayed on smartablate generator.There was a suspected perforation.It was confirmed with soundstar.The bwi sales consultant reported that 5.5 l of fluid was removed, and a cell saver device was used.The procedure was abandoned.Graph, dashboard, vector, visitag force visualization features were used.The visitag module was used, the parameters for stability used were 2mm, 2.5 secs, 25% at 3g.Tag index color option was used prospectively.Max wattage used: 40; total lesions: 92; total ablation time: 28 min 42 secs (20 secs for steam pop lesion); total fluid: 670ml.Surpoint time was 3 sec.Other bwi products: sound star, penta ray, and preface.The second ablation catheter will be returned for analysis.Regarding the ¿floating ablation signal, unipolar m-1 had no baseline electrogram.Comparing to the other three electrodes looked as if there was motion artifact on m-1.A smart ablate generator with serial number (b)(4) was used.Correct catheter settings were selected on the generator.The pump was not switching from ¿low¿ to ¿high¿ flow during ablation.No issues with pump.Pump was behaving as designed.Steam pop is not mdr-reportable.Low impedance is not mdr-reportable.All deaths were bwi fda approved ¿ ce mark devices are involved are reportable.".

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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).

Manufacturer Narrative

On 30-may-2022, the product investigation was completed.It was reported that an 80-year-old male patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.The patient suffered cardiac tamponade requiring pericardiocentesis, cardiac arrest requiring cpr and surgical intervention, and ultimately death.Device evaluation details: visual analysis revealed that no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, electrical, temperature and force features were tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device 30728980l number, and no internal actions related to the complaint were found during the review.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The ifu (instruction for use) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.There may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.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® SF UNI-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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14518110
• MDR Text Key: 292785628
• Report Number: 2029046-2022-01137
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• 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,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/26/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2023
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30728980L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2022
• 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; CARTO VISITAG MODULE; HEARTSPAN NEEDLE; SMARTABLATE GENERATOR; SOUNDSTAR CATHETER; THERMOCOOL SMARTTOUCH; UNSPECIFIED PUMP
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention; Death
• Patient Age: 80 YR
• Patient Sex: Male