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

Catalog Number SEE H10.

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Pleural Effusion (2010); Pericardial Effusion (3271)

Event Date 12/14/2022

Event Type  Injury  

Manufacturer Narrative

Device investigation details: 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 (mre) cannot be conducted because no lot number was provided by the customer.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: catalog should reflect as 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 that a female patient underwent an ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter.The patient suffered pericardial effusion and pleural effusion.The patient was prepped in the centers usual fashion for a ventricular tachycardia (vt) ablation.A quad catheter was advanced into the right ventricle (rv).A soundstar catheter was then advanced from the femoral vein and into the heart to create sound maps of the different chambers of the heart.From the intracardiac echocardiography (ice) views of the ventricles, a pre-existing pericardial effusion was noticed and the patient¿s blood pressure was stable.Next, the physician prepared for transseptal puncture.The pentaray catheter was advanced via retrograde aortic.Fast anatomical mapping (fam) of the aorta and left ventricle (lv) was created.The rv was paced and voltage collection of the lv was completed.Once an area of scar was determined to be the area of interest for ablation, the thermocool® smart touch¿ bi-directional navigation catheter was advanced through the transseptal puncture and ablation was completed.Following, a cavotricuspid ishmus (cti) ablation was completed in the right atrium.Ice was used again to check the pre-existing pericardial effusion, which did not change in size since the beginning of the case.The patient became hypotensive and once determined that it was not due to the pre-existing pericardial effusion or a bleed from the groin, the patient was sent to computed tomography (ct) to determine the cause.Post ct, it was determined that the patient had pleural effusion, which the physician believed it may have been from advancing the agilis sheath into the superior vena cava (svc).Surgery was not delayed due to the reported event.The procedure was successfully completed.There was a patient consequence.A medical intervention was required.Additional information was received indicating the adverse event was discovered post use of biosense webster products.Physician believes that the cause of this adverse event is due to the advancement of the agilis sheath from the femoral vein into the superior vena cava (svc).Patient was sent to get ct images.The patient¿s outcome from the adverse event was reported as fully recovered (no residual effects).A st.Jude brk transsept reported as al needle was used for the transseptal puncture performed.There was no evidence of steam pop.The event occurred post ablation, prior to ending the case.The flow setting for the irrigated catheter used was 15ml/min.Correct catheter settings was selected on the smartablate generator and the smartablate pump was not switching from ¿low¿ to ¿high¿ flow during ablation.No error messages observed on biosense webster equipment during the procedure.Force visualization features used were dashboard, vector and visitag.Parameters for stability for the visitag module used were time: 3s, range: 2.5mm, fot: 25%, 3s and size: 2mm.No additional filter used with the visitag.Color options used prospectively was impedance drop.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 19-may-2023, it was noticed the patient's gender was incorrectly reported as "female" in section b5 event description of the 3500a initial medwatch report.However, the patient was male.Please consider this as a correction.

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 16119781
• MDR Text Key: 306881017
• Report Number: 2029046-2023-00058
• 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,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• 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
• Date Manufacturer Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: AGILIS SHEATH; CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-WW; SMARTABLATE PUMP KIT-WW; SMARTABLATE REMOTE KIT-WW; ST. JUDE BRK TRANSSEPTAL NEEDLE; UNKNOWN QUAD CATHETER; UNK_PENTARAY; UNK_SOUNDSTAR
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male