MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number NR7TCSIY

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 08/17/2022

Event Type  Injury  

Manufacturer Narrative

The biosense webster, inc.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.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.Manufacturer's reference number: pc- (b)(4).

Event Description

It was reported that a 61-year-old male patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and suffered a cardiac tamponade requiring pericardiocentesis.It was reported that toward the end of the procedure, the coronary sinus (cs) was cannulated with the rmt ablation catheter under remote magnetic navigation.The patient became tachycardic, and intracardiac echocardiography (ice) was then used to check the heart.A pericardial effusion was noted.The catheter went into a cs branch, resulting in a possible perforation- no ablation was performed in this location.A pericardiocentesis was performed, about 350 ml of fluid was removed and given back to the patient.The tube was not left in place.The patient was hemodynamically stable at the time of the call.The procedure was abandoned.This adverse event was discovered during use of bwi products.The patient was being monitored at the time of the call.A transseptal puncture was not performed.Prior to noting the pericardial effusion, ablation was performed in lvot, rvot, and aortic cusps.There was no evidence of a steam pop.The event occurred during mapping.An irrigated catheter was used in the event, the flow setting was 15/30 ml per ifu.No error messages were observed on the biosense webster equipment during the procedure.The effusion was discovered/noticed due to patient heart rate increase.The patient was admitted.However; there was no report of extended hospitalization.There was a suspected perforation.It was confirmed with soundstar.There was no evidence of any effusion present before the procedure.The visitag module was used, parameters for stability used was impedance.Max wattage used: 50 w; total lesions: 11; total ablation time: 15min, 31sec; total fluid: 1029 ml.Other bwi products: rmt thermocool, soundstar.The ablation catheter will be returned for analysis.

Manufacturer Narrative

The device evaluation was completed on 21-sep-2022.It was reported that a 61-year-old male patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and suffered a cardiac tamponade requiring pericardiocentesis.It was reported that toward the end of the procedure, the coronary sinus (cs) was cannulated with the rmt ablation catheter under remote magnetic navigation.The patient became tachycardic, and intracardiac echocardiography (ice) was then used to check the heart.A pericardial effusion was noted.The catheter went into a cs branch, resulting in a possible perforation- no ablation was performed in this location.A pericardiocentesis was performed, about 350 ml of fluid was removed and given back to the patient.The tube was not left in place.The patient was hemodynamically stable at the time of the call.The procedure was abandoned.Device evaluation details: a visual inspection and an evaluation of all features of the device were performed following biosense webster inc.(bwi) procedures.Visual analysis revealed no damage or anomalies on the device.Per the event, several tests were performed.Electrical, temperature, and no issues were observed.In addition, the product was deflecting and irrigating correctly.The device was connected to the carto 3 system, and the device was visualized and recognized correctly; however, the error 105 ¿magnetic sensor error¿ appeared on the carto 3 screen.The catheter was dissected, and it was found that the tip lost the sensor's wire's continuity, causing the magnetic sensor error.A manufacturing record evaluation was performed for lot 30826886m and no internal action related to the complaint were found during the review.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 instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.The root cause of the adverse event remains unknown.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: NAVISTAR® RMT THERMOCOOL® ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 15419878
• MDR Text Key: 299880136
• Report Number: 2029046-2022-02215
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: 10846835008500
• 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: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NR7TCSIY
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 30826886M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/07/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2022
• 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: UNK_CARTO 3; UNK_SOUNDSTAR
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male