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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Tachycardia (2095)

Event Date 05/03/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced ventricular tachycardia requiring surgical intervention.It was reported, that while navigating with the ablation catheter and crossing over the aorta valve, coming in the left main area when it was noticed that the patient's sinus rhythm changed and the patient's heartbeat went down rapidly developed into a ventricular tachycardia.The physician started calling for medication to be administered, atropine and epinephrine, and a stent on the left main, as well as an impella pump (left ventricular assist device (lvad)) was also added.The physician stated that when crossing the aorta valve it may have caused a spasm that triggers the rhythm change and the rest.The patient is in stable condition.

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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced ventricular tachycardia requiring surgical intervention.It was reported, that while navigating with the ablation catheter and crossing over the aorta valve, coming in the left main area when it was noticed that the patient's sinus rhythm changed and the patient's heartbeat went down rapidly developed into a ventricular tachycardia.The physician started calling for medication to be administered, atropine and epinephrine, and a stent on the left main, as well as an impella pump (left ventricular assist device (lvad)) was also added.The physician stated that when crossing the aorta valve it may have caused a spasm that triggers the rhythm change and the rest.The patient is in stable condition.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.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 no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.The physician stated he thought the left main spasmed and did not relax when going retrograde over the aortic valve with the thermocool® smart touch® sf bi-directional navigation catheter.Not caused by product malfunction.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 ref.# (b)(4).

Manufacturer Narrative

On 11-may-2023, additional information was received indicating the adverse event was discovered during use of biosense webster products.Physician stated he thought the left main spasmed and did not relax when going retrograde over the aortic valve with the thermocool® smart touch® sf bi-directional navigation catheter, not caused by a product malfunction.Patient had an impella placed and a stent placed in the left main as intervention.The patient¿s outcome from the adverse event was reported as fully recovered and home.Patient required extended hospitalization because of the adverse event.Unsure of details.A smartablate genterator was used during the case.On 24-may-2023, the bwi product analysis lab received the complaint device for evaluation.The product 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 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: 16905132
• MDR Text Key: 314937824
• Report Number: 2029046-2023-00991
• 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,Followup
• Report Date: 07/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• 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: 30986263L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/03/2023
• 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: SMARTABLATE GENERATOR SPARE-US
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female