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

Catalog Number NR7TCSIY

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 09/26/2023

Event Type  Injury  

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure using the navistar® rmt thermocool® electrophysiology catheter.During rf (radiofrequency) delivery, the patient experienced cardiac tamponade that required pericardiocentesis.There was difficult venous entry with the introducer sheaths as the patient had tortuous anatomy, and that the vizigo had to be put through a larger, 14 fr.Sheath for access.The physician also had difficulty manipulating the pentaray within the vizigo sheath which was transseptal in the left atrium (la).The pentaray was removed and exchanged with an rmt/stereotaxis catheter to complete mapping and begin ablating in the la (manual catheter manipulation was switched to robotic, the case was continued using the stereotaxis system).During rf delivery it was noticed on intracardiac echo that the patient had an "evolving effusion." the patient was hemodynamically stable so ablation was continued until the pulmonary veins were electrically isolated.The effusion was getting larger so the procedure was stopped and interventional cardiology was brought in.A pericardiocentesis was also performed.Afterward, the patient was in stable condition.The physician did not believe the effusion was caused by a product issue.The effusion occurred during the transeptal phase of the procedure.No issues with the ablation catheter were noted.Although additional information reported effusion occurred during the transseptal phase, this adverse event is being captured under the ablation catheter, as the adverse event was reported to be originally noticed during rf delivery and the cardiac ablation catheter is the only catheter to deliver rf energy directly with cardiac tissue.

Manufacturer Narrative

On 23-oct-2023, the bwi product analysis lab was received for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrial fibrillation ablation procedure using the navistar® rmt thermocool® electrophysiology catheter.During rf (radiofrequency) delivery, the patient experienced cardiac tamponade that required pericardiocentesis.There was difficult venous entry with the introducer sheaths as the patient had tortuous anatomy, and that the vizigo had to be put through a larger, 14 fr.Sheath for access.The physician also had difficulty manipulating the pentaray within the vizigo sheath which was transseptal in the left atrium (la).The pentaray was removed and exchanged with an rmt/stereotaxis catheter to complete mapping and begin ablating in the la (manual catheter manipulation was switched to robotic, the case was continued using the stereotaxis system).During rf delivery it was noticed on intracardiac echo that the patient had an "evolving effusion." the patient was hemodynamically stable so ablation was continued until the pulmonary veins were electrically isolated.The effusion was getting larger so the procedure was stopped and interventional cardiology was brought in.A pericardiocentesis was also performed.Afterward, the patient was in stable condition.The physician did not believe the effusion was caused by a product issue.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed, and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device 31092770m number, and no internal actions related to the reported complaint condition were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, 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.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17986928
• MDR Text Key: 326302901
• Report Number: 2029046-2023-02404
• 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: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: NR7TCSIY
• Device Lot Number: 31092770M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2023
• 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 VIZIGO SHEATH; UNK_PENTARAY
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Sex: Female