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 Arrest (1762)

Event Date 03/17/2023

Event Type  Death  

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30974876l number, and no internal actions related to the complaint was found during the review.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 ref.# (b)(4).

Event Description

It was reported that a patient underwent an afib ¿ paroxysmal ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced a cardiac arrest requiring resuscitation but ultimately passed away.It was reported that during an afib/left atrial flutter ablation the patient expired.While mapping and ablating in the left atrium, the flutter terminated but premature atrial contractions (pac) were still occurring.The patient then experienced a decrease in heart rate and blood pressure resulting in decreased ejection fraction.The patient required chest compressions and after 45 minutes the patient expired.The ablation power was 50 watts with irrigation flow rate of 15 ml/min.They reported no unusual impedance changes during rf delivery.The physician did not indicate if they believed bwi products contributed to the patient event.Additional information received indicated the physician¿s opinion on the cause of death was that after flutter was terminated, patient was bradycardic, pressure lowered, heart rate continued to decrease.Patients ¿native conduction system was unable to recover on its own after having anesthesia support and pacing with catheters.Chest compressions were performed for about 45 minutes.No effusion was visualized and no reason to believe a perforation occurred.All force visualization features were used.Visitag module was used, parameters for stability used was standard recommended presets.Tag size: 3mm, time: 3 seconds, force over time (fot) of 25% over 3g.No additional filter used with the visitag.Time was used.

• 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: 16742592
• MDR Text Key: 313313860
• Report Number: 2029046-2023-00817
• 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: Other
• Type of Report: Initial
• Report Date: 04/14/2023

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: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30974876L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/17/2023
• Initial Date FDA Received: 04/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2023
• 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: CARTO 3 SYSTEM
• Patient Outcome(s): Death; Required Intervention