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

Catalog Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Arrest (1762)

Event Date 11/06/2023

Event Type  Injury  

Event Description

It was reported a patient underwent a pvc/afib cardiac ablation procedure which included the use of a thermocool smarttouch sf ablation catheter experienced cardiac arrest.It was reported they were mapping using the optrell catheter and then began ablating below the valve.About an hour after burning in the left ventricle, and the physician decided to check the vein in the left atrium.The physician had the nurse come off pacing, they went back to the map, and the anesthesiologist said the patient had no blood pressure at all.The patient's vitals were how they discovered and confirmed the issue.The medical intervention provided was the physician performed chest compressions for 30 seconds and the pressure began to return.The medical team also "shot the coronaries" administering epinephrine, performed coronary angiography, and then "pulled from the left side, and did a cavotricuspid ishmus (cti) line." the patient fully recovered and discharged the next day.The physician's opinion on the cause is the patient condition and procedure, and believed the issue to be an electromagnetic disassociation.The patient had a medtronic pacemaker.The overnight stay was not interventional.

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.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

On 5-dec-2023, 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.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

On (b)(6) 2024, the product investigation was completed.It was reported a patient underwent a pvc/afib cardiac ablation procedure which included the use of a thermocool smarttouch sf ablation catheter experienced cardiac arrest.It was reported they were mapping using the optrell catheter and then began ablating below the valve.About an hour after burning in the left ventricle, and the physician decided to check the vein in the left atrium.The physician had the nurse come off pacing, they went back to the map, and the anesthesiologist said the patient had no blood pressure at all.The patient's vitals were how they discovered and confirmed the issue.The medical intervention provided was the physician performed chest compressions for 30 seconds and the pressure began to return.The medical team also "shot the coronaries" administering epinephrine, performed coronary angiography, and then "pulled from the left side, and did a cavotricuspid ishmus (cti) line." the patient fully recovered and discharged the next day.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed and during the analysis, a high force/negative vector were observed.For this condition, a manufacturing investigation was performed, and it was concluded that the force issue observed during the analysis is related to the manufacturing process since the electrical wire¿s assembly was found incorrectly executed.A manufacturing record evaluation was performed for the finished device 31110642l number, and no internal actions related to the reported complaint condition were identified.The root cause of the adverse event remains unknown.The physician's opinion on the cause is the patient condition and procedure.In addition, no device malfunction was reported, 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 the 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: 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: 18254168
• MDR Text Key: 329549714
• Report Number: 2029046-2023-02812
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/09/2024

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: D134805
• Device Lot Number: 31110642L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/06/2023
• Initial Date FDA Received: 12/04/2023
• Supplement Dates Manufacturer Received: 12/05/2023; 01/23/2024
• Supplement Dates FDA Received: 12/28/2023; 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2023
• 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: OCTARAY CATHETER.; OPTRELL CATHETER.; REPROCESSED SOUNDSTAR CATHETER.; SMARTABLATE GENERATOR.
• Patient Outcome(s): Life Threatening; Required Intervention