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

Event Date 04/19/2022

Event Type  Injury  

Event Description

It was reported that an athletic/healthy 40-year-old male patient underwent an atrial fibrillation (afib) ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and suffered cardiac tamponade requiring pericardiocentesis and cardiac arrest requiring cpr.It was reported that during an afib case, a pericardial effusion was noticed.The injury was discovered when the patient¿s blood pressure dropped at the end of the procedure.The pericardial effusion was confirmed by ice.The medical intervention provided was cpr and pericardiocentesis.The caller stated that the amount of fluid removed was unknown at the time of the call and that the pericardiocentesis was being performed at that time.The patient was reported to be in stable condition.The reason for the injury was unknown.Additionally, it was reported that the impedance displayed on the smartablate generator "jumped" during ablation.The procedure continued.The impedance "jump" was displayed on the smartablate generator and the catheter was removed from the body.The char was discovered on the tip of the catheter after inspection.They assumed a steam pop occurred due to the impedance jump and char on the catheter, however, a steam pop was not felt by the physician.They replaced the catheter and the procedure continued.Additional information was received on 21-apr-2022.The physician¿s opinion on the cause of this adverse event is that it was user error/patient anatomy.Medical intervention provided was the administration of medication and blood was tapped from the heart (800ml).According to the bwi sales consult the patient was recovering when they last checked.The patient did require extended hospitalization because of the adverse event, he stayed at least one extra night.Relevant history: the patient is a healthy male, some abnormal anatomy and large atrium likely the cause of his afib.A smartablate generator with serial number (b)(4) was used.A transseptal puncture was performed with a brk needle.Prior to noting the effusion, ablation was performed.The effusion occurred after almost an hour of ablation.There was evidence of steam pop; several impedance spikes occurred throughout case while ablating at 50w.The event occurred at the very last lesion set.He was 5 seconds from stopping ablation, pulling catheter, and being done when the pressure dropped.An irrigated catheter was used in the event, the flow setting was 30ml/min while ablating.Correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.No error messages were observed on biosense webster equipment during the procedure.No force visualization features were used, rmt catheter was used.Time parameter for stability was used.No additional filter used with the visitag.Time color option was used prospectively.There was a cutoff early in the case and then 2-3 more times the bwi sales consultant called off the ablation due to observational impedance spikes.The generator parameters were power 50 w and power control mode.At the time of effusion event the event there was no noted impedance spike.Baseline impedance was around 100 ohms.The char was located on the tip of the electrode.The system did not present any error messages and the physician/user did not see any product problem.There were no issues related to temperature and flow on the catheter that the bwi sales consultant was aware of.Act is unknown.Pump with serial number (b)(4) was used.The patient has not exhibited any neurological symptoms since the procedure was completed that the bwi sales consultant is aware of.They followed up the next day and they were told that the patient recovered well and is "fine".The duration of ablation used was greater 120 seconds.The physician does drag lesions and goes till 999 seconds.According to the bwi sales consultant, the physician does a ¿ridiculous amount¿ of burn time and frequently stays in the same area for too long.An rmt catheter was used.Heparinized normal saline was used as the irrigation fluid.Mostly manual ablation tags were used.Rmt does not recognize visitags so manual ablation tags were taken.Additional information was received on 30-apr-2022.The bwi sales consultant does not know if the patient exhibited any neurological symptoms since the procedure was completed.The high flow was the doctors normal preset which is 30 ml.There were no errors.Additional information was received on 5-may-2022.The bwi sales consultant confirmed that the patient did suffer cardiac arrest requiring cpr.

Manufacturer Narrative

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.(b)(4).

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device (b)(4) number, and no internal action related to the complaint was found during the review.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: 14440841
• MDR Text Key: 292162367
• Report Number: 2029046-2022-01062
• 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: 06/16/2022

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: NR7TCSIY
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 30682945M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/19/2022
• Initial Date FDA Received: 05/19/2022
• Supplement Dates Manufacturer Received: 05/20/2022
• Supplement Dates FDA Received: 06/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/29/2021
• 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: NAVISTAR RMT THERMOCOOL; NAVISTAR RMT THERMOCOOL; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US; UNK BRK NEEDLE
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 40 YR
• Patient Sex: Male