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 08/12/2022

Event Type  Injury  

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.Initial reporter email: (b)(6).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a female patient underwent a ventricular idiopathic ventricular tachycardia (idvt-left) procedure with a navistar® rmt thermocool® electrophysiology catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that as the physician was gathering his last ultrasound images to end the case, that intracardiac echocardiography (ice) revealed a pericardial effusion.The procedure was complete when this was discovered.The patient did not display any symptoms.A pericardiocentesis was performed but it is unknown how much fluid was removed.Patient was stable and being held overnight for observation.The physician did not know the cause of the effusion, as it was noticed at the end of the case; 50w used to ablate.There were two catheters in the body when the effusion was discovered; the - navistar® rmt thermocool® electrophysiology catheter ablation catheter and the soundstar catheter.The patient outcome of the adverse event is unknown; at the end of the procedure patient was stable.The patient was monitored overnight.A smartablate generator was used.A transseptal puncture was performed using baylis nrg needle.There was no evidence of steam pop.The navistar® rmt thermocool® electrophysiology catheter was used with the following flow settings: 17ml/min low flow and 30ml/min high flow.Correct catheter settings were selected on the smartablate generator and the pump was switching from ¿low¿ to ¿high¿ flow during ablation.

Manufacturer Narrative

It was reported that a female patient underwent a ventricular idiopathic ventricular tachycardia (idvt-left) procedure with a navistar® rmt thermocool® electrophysiology catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that as the physician was gathering his last ultrasound images to end the case, that intracardiac echocardiography (ice) revealed a pericardial effusion.The procedure was complete when this was discovered.The patient did not display any symptoms.A pericardiocentesis was performed but it is unknown how much fluid was removed.Patient was stable and being held overnight for observation.The physician did not know the cause of the effusion, as it was noticed at the end of the case; 50w used to ablate.There were two catheters in the body when the effusion was discovered; the - navistar® rmt thermocool® electrophysiology catheter ablation catheter and the soundstar catheter.The patient outcome of the adverse event is unknown; at the end of the procedure patient was stable.Device evaluation details: on 8-sep-2022, the product was returned to biosense webster inc (bwi) for evaluation.The evaluation has been completed.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Per the event, several tests were performed.The magnetic test was performed, and the catheter cannot be recognized and visualized due to error 101 observed (eeprom issue).The temperature test was performed, and no issue was observed.In addition, the product was irrigated correctly.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The root cause of the adverse event remains unknown.The root cause of the eeprom issue remains unknown.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.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the adverse event.Investigation findings: software problem identified (c10) / investigation conclusions: cause traced to component failure (d02) / component code: memory/storage (g0200702) were selected as related to the eeprom error which was determined to be unrelated to the adverse event.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 15367253
• MDR Text Key: 299359649
• Report Number: 2029046-2022-02132
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/07/2022

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: 30839001M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/12/2022
• Initial Date FDA Received: 09/07/2022
• Supplement Dates Manufacturer Received: 09/08/2022
• Supplement Dates FDA Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2022
• 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: 8.5F SHEATH WITH CURVE VIZ MDC; BAYLIS NRG NEEDLE; SMARTABLATE GENERATOR KIT-US; SOUNDSTAR ECO SMS 8F CATHETER; UNKNOWN PUMP
• Patient Outcome(s): Life Threatening; Required Intervention