MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number BNI75TCDFH

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 02/03/2023

Event Type  Injury  

Manufacturer Narrative

The bwi 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 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 idvt ¿ right ablation procedure with a soundstar eco and ez steer¿ thermocool® nav bi-directional catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that the patient suffered a pericardial effusion.They stated that during the fist ablation at 1 min 54 seconds in it was noted by anesthesia that the patient¿s pressure dropped.The ice (intracardiac echocardiography) catheter was used to confirm a large pericardial effusion.A pericardiocentesis was performed and 3345 cc's of fluid was removed from the pericardial space.The patient also received 1005 cc's back through one of the groin sheaths.A cardiothoracic surgeon was brought in for consult, and the patient was then taken to surgery.They stated that the patient was currently in the surgery at the time of the call.They reported that the wattage used ranged from 5-23 watts with 15 watts as the average.They stated there was speculation that the perforation was caused by ablation inside the cs, but had not had a chance to have a real discussion with the physician.Other bwi products in use: decanav and soundstar.The adverse event occurred on the date complaint was reported.The adverse event was discovered post use of biosense webster products.Pericardial drain was performed.Outcome of the adverse event was improved - ct surgery noted tear in coronary sinus vein.No evidence of steam pop.The event occurred during the ablation phase.Irrigated catheter was used in the event, the flow setting was normal settings.Correct catheter settings were selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.No error messages observed on biosense webster equipment during the procedure.All force visualization features were used.Visitag module was used, parameters for stability used were 5-16g, 3s, 50% 5g, 3mm.Additional filter used with the visitag was respiratory gated.Color options used prospectively was ablation index.Since the 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.

Manufacturer Narrative

On 3-mar-2023, the product investigation was completed.It was reported that a patient underwent an idvt ¿ right ablation procedure with a soundstar eco ez steer¿ thermocool® nav bi-directional catheter.The patient suffered cardiac tamponade requiring pericardiocentesis.It was reported that the patient suffered a pericardial effusion.They stated that during the fist ablation at 1 min 54 seconds in it was noted by anesthesia that the patient¿s pressure dropped.The intracardiac echocardiography (ice) catheter was used to confirm a large pericardial effusion.A pericardiocentesis was performed and 3345 cc's of fluid was removed from the pericardial space.The patient also received 1005 cc's back through one of the groin sheaths.A cardiothoracic surgeon was brought in for consult, and the patient was then taken to surgery.They stated that the patient was currently in the surgery at the time of the call.Device evaluation details: visual analysis revealed no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, electrical, and temperature 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 30901323m 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.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: EZ STEER¿ THERMOCOOL® NAV BI-DIRECTIONAL 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: 16479237
• MDR Text Key: 310632849
• Report Number: 2029046-2023-00461
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835003338
• UDI-Public: 10846835003338
• 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: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: BNI75TCDFH
• Device Catalogue Number: BNI75TCDFH
• Device Lot Number: 30901323M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2022
• 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: CARTO 3 SYSTEM.; CARTO VISITAG MODULE.; DECANAV CATHETER.; SOUNDSTAR CATHETER.; UNSPECIFIED GENERATOR.
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male