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 Vascular Dissection (3160)

Event Date 01/04/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia - left (l-idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a vascular dissection which required surgical intervention and prolonged hospitalization.It was reported by the biosense webster inc.Representative that when the physician was advancing the thermocool® smart touch® sf bi-directional navigation catheter over the aortic arch, the catheter would not advance.A wire was advanced, and a pigtail catheter was also put in.Contrast was injected and there was a visible false lumen.Cardiovascular surgery was called.The patient is still on the ep lab table and is stable at this time.The patient care plan is unknown at this time.They were currently doing a transesophageal echocardiogram (tee) and a cta was also ordered.Additional information was received.The issue was caused by thermocool® smart touch® sf bi-directional navigation catheter.The event was discovered during use.The physician believes that the issue was caused by a procedural issue.Not due to a product malfunction.The patient was flown to (b)(6) clinic.They received surgical repair of the ascending aortic arch.Outcome of the adverse event was fully recovered (no residual effects).The patient has recovered and is stable.Patient required extended hospitalization because of the adverse event because the patient required surgery and is recovering.Other relevant history- chest radiation for breast cancer, pvc, mr, ckd, gerd, scoliosis.Generator information was a smart ablate generator; m490002; g4c-3515.There was no issue with the catheter.The false lumen is in reference to the false lumen of the aorta due to the dissection.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 18-jan-2023.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.Clarification is being requested on the event date of (b)(6) 2022 as the procedure date provided is (b)(6) 2023.However, no further information has been made available.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

In the 3500a initial, it was reported that clarification was being requested on the event date of 04-jan-2022 as the procedure date provided was (b)(6)2023.However, no further information had been made available.Additional information was received on 30-jan-2023 clarifying that the event date was 04-jan-2023.Therefore, updated the b3.Date of event field.The device evaluation was completed on 14-feb-2023.It was reported that a patient underwent an idiopathic ventricular tachycardia - left (l-idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a vascular dissection which required surgical intervention and prolonged hospitalization.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed that no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, electrical, temperature and force features were tested and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.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.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.The root cause of the adverse event remains unknown.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 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: 16254512
• MDR Text Key: 308285410
• Report Number: 2029046-2023-00173
• 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
• Report Date: 02/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2023
• 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: 30928393L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/15/2022
• 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: OCTA,STD,48P,2-2-2-2-2,D-CURVE; SMARTABLATE GENERATOR KIT-US
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 53 YR
• Patient Sex: Female
• Patient Weight: 75 KG