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 Problems Signal Artifact/Noise (1036); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 08/19/2022

Event Type  Injury  

Event Description

It was reported that a male patient in 70's underwent an ischemic ventricular tachycardia (isvt) ablation procedure with two navistar® rmt thermocool® electrophysiology catheter¿s.The patient suffered a cardiac tamponade requiring a pericardiocentesis.The patient suffered a pericardial effusion.The effusion was initially noted during intracardiac echo (ice) (soundstar) imaging pre-transseptal access.The case was continued while monitoring the effusion.After gaining transseptal access, mapping, and some ablation (with the second ablation catheter- lot #: unknown), the effusion had grown.A pericardiocentesis was performed, with about 800 ml removed.The patient was stable.The adverse event was discovered during use of biosense webster, inc.The physician stated she was unsure of the cause of the adverse event.The patient outcome of the adverse event was unknown.It is also unknown if the patient required extended hospitalization.Transseptal puncture was performed with a versacross wire with fixed sheath- baylis.Prior to noting the cardiac tamponade, ablation was not performed.There was no evidence of a steam pop.The event occurred during pre-transseptal access.The irrigated catheter flow setting was rmt tc, 15/30 ml.No error messages were observed on biosense webster equipment during the procedure.The procedure was abandoned.There was no evidence of any effusion present before the procedure.Also, it was reported that the second electrode on the initial ablation catheter (navistar® rmt thermocool® electrophysiology catheter /lot number: 30829977m) was bad.It was black on the map and had noisy signals.The cable was replaced without resolution.The catheter was replaced with a navistar® rmt thermocool® electrophysiology catheter (lot # unknown) and the issue resolved.The procedure was continued.Additional information was received.The biosense webster, inc.Representative¿s knowledge, the patient did not require extended hospitalization.Relevant tests: prior to the case, an echo was performed on the patient and no effusion was noted.No other relevant history.A transseptal puncture was performed with a baylis versacross access solution with pigtail wire.There was no evidence of steam pop.Effusion was noted prior to ablation.Flow settings were standard for st ablator; 17 ml/min for <30w, 30 ml/min for >30w.No error messages were observed on biosense webster equipment.The issue of the second electrode was black on the map and had noisy signals was assessed as not mdr reportable.The risk to the patient was low.Since the adverse event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.The adverse event was assessed as mdr reportable under both of the navistar® rmt thermocool® electrophysiology catheter¿s used in the procedure.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 26-sep-2022.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 additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The device evaluation was completed on 07-oct-2022.It was reported that a male patient in 70s underwent an ischemic ventricular tachycardia (isvt) ablation procedure with two navistar® rmt thermocool® electrophysiology catheter¿s.The patient suffered a cardiac tamponade requiring a pericardiocentesis.Also, it was reported that the second electrode on the initial ablation catheter (navistar® rmt thermocool® electrophysiology catheter /lot number: 30829977m) was bad.It was black on the map and had noisy signals.The cable was replaced without resolution.The catheter was replaced with a navistar® rmt thermocool® electrophysiology catheter (lot # unknown) and the issue resolved.The procedure was continued.The product was returned to biosense webster (bwi) for evaluation.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 electrical and temperature 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 batch number, and no internal actions were identified.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 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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15407854
• MDR Text Key: 299762521
• Report Number: 2029046-2022-02204
• 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,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• 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: 30829977M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2022
• 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: NAVISTAR RMT THERMOCOOL; NON BWI-BAYLIS-VERSACROSS WIRE WITH FIXED SHEATH; SMARTABLATE GENERATOR KIT-US; UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE; UNK_SOUNDSTAR
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male