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

Catalog Number SEE H10

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

Patient Problem Insufficient Information (4580)

Event Date 12/05/2023

Event Type  Death  

Manufacturer Narrative

Device investigation details: available information 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 (mre) cannot be conducted because no lot number was provided by the customer.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.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.Note: date of death was not provided, as such, field b2.Date of death has been defaulted to the event date: 5-dec-2023.D4.Catalog: unk_smart touch bidirectional sf 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 a patient underwent a ventricular tachycardia cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and patient has died.Near the end of the patient's procedure, the physician was informed of an anesthesia related complication on initial presentation.The case was quickly completed and no report was submitted for any product related complication.At the end of the ablation, the anesthesiologist indicated to the surgeon that the patients stats (pressure, oxygen) had a slight drop.After 5-6 hours, when the physician was finished delivering ablation therapy, the anesthesiologist had a conversation with the physician which led to the conclusion of the case.Additional physicians were called to assess the patient and non-essential team-members exited the area.Throughout the procedure the physician had used intracardiac ultrasound as well as other health indicators (blood pressure) to monitor the health status of the patient.The physician reported that the carto system and products (ablation and diagnostic catheters, sheaths, generator, irrigation pump) were not involved in the adverse event.Due to limited information, a cause of death cannot be determined.No malfunctions have been reported.Without sufficient information, the ablation catheter cannot be completely dissociated as a contributor due to rf energy being delivered and procedure was completed.

• 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: 18794471
• MDR Text Key: 336393491
• Report Number: 2029046-2024-00659
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/27/2024

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 Catalogue Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Sex: Male