MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/17/2022

Event Type  Death  

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.Catalog is "unk_smart touch bidirectional sf" (the ablation catheter information was not provided, as such, the event is being conservatively reported against a bwi ablation catheter.Additional follow up for product information is being performed).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 premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (ablation catheter) and the patient suffered cardiac tamponade requiring a pericardiocentesis.It was reported by the bwi representative that during a pvc procedure the physician noticed a cardiac effusion.The physician was able to confirm the injury with the intracardiac echocardiography (ice) ultrasound system via the soundstar catheter.Pericardiocentesis was utilized to intervene with the injury and 1200 ml of fluid was removed from the patient."the physician believes that he may have perforated the septum with the ablation catheter" which caused the injury.The patient has passed away on (b)(6) 2022 in the lab.In the physician¿s opinion, the cause of death was the patient¿s condition and the pvc ablation in right ventricular outflow tract (rvot) as patient developed the cardiac tamponade.No transseptal puncture performed.No evidence of steam pop.Event occurred during the ablation phase.The flow setting for the irrigated catheter used was the standard setting.Correct catheter settings was selected on the smartablate generator and the pump switching was not from ¿low¿ to ¿high¿ flow during ablation.No error messages observed on biosense webster equipment during the procedure.Force visualization features used were¿ graph, dashboard, vector and visitag.Parameters for stability for the visitag module used were range: 2.5, time: 3, force over time (fot) 3 and 25%, tag size of 3.Additional filter used was respiratory gated.Color options used prospectively was force time intervel (fti).

Manufacturer Narrative

On 30-dec-2022, additional information was received providing the product details of the ablation catheter.The product code and lot number were provided and all appropriate fields have been updated.D4.Catalog, d4.Lot, d4.Expiration date, d4.Unique identifier (udi) g4.Pma/ 510(k) and h4.Device manufacture date have been updated.Additionally, it was reported the device is not available for return.Device investigation details: additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30892874l 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 ref.# (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 15999629
• MDR Text Key: 305676232
• Report Number: 2029046-2022-03157
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30892874L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2022
• 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.; SMARTABLATE GENERATOR SPARE-US.; SOUNDSTAR ECO GE 8F CATHETER.; UNKNOWN PUMP.
• Patient Outcome(s): Death; Required Intervention
• Patient Sex: Female