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 Heart Block (4444)

Event Date 03/27/2024

Event Type  Injury  

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and carto vizigo sheath and the patient experienced a complete heat block that required pacemaker implantation.It was reported that the patient went into a complete heart block before gaining transeptal access.No ablation had been performed.There was very slow/no a-to-v conduction for the signals displayed on the carto 3 system.The patient's blood pressure decreased.The medical intervention provided was that the ablator was put into the ventricle and the medical team paced the v from the ventricle and a temporary pacemaker was put into the patient.The patient was reported to be in stable condition.The procedure was aborted.It was unknown how the injury occurred.The ablation catheter and the vizigo sheath were inside of the patient when the injury occurred.Physician's opinion on the cause of the adverse event is patient condition.Other relevant history includes: patient had a coronary artery bypass graft (cabg) about 10 years ago.Before the case the patient had very slow conduction and this was then proved when the medical team got a long h-v as soon as catheters were placed in the body.Patient required extended hospital stay, and the doctor placed a permanent pacemaker in the patient.

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.Manufacturer's reference number: (b)(4).Biosense webster manufacturer's reference number (b)(4).Has two reports: 1) manufacturer report number 2029046-2024-01318 for the thermocool smarttouch (this current report) 2) manufacturer report number 2029046-2024-01319 for the vizigo sheath.

Manufacturer Narrative

On 24-apr-2024, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and carto vizigo sheath and the patient experienced a complete heat block that required pacemaker implantation.It was reported that the patient went into a complete heart block before gaining transeptal access.No ablation had been performed.There was very slow/no a-to-v conduction for the signals displayed on the carto 3 system.The patient's blood pressure decreased.The medical intervention provided was that the ablator was put into the ventricle and the medical team paced the v from the ventricle and a temporary pacemaker was put into the patient.The patient was reported to be in stable condition.The procedure was aborted.It was unknown how the injury occurred.The ablation catheter and the vizigo sheath were inside of the patient when the injury occurred.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 no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device number lot 31229104l and no internal action related to the complaint was found during the review.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.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 physician's opinion on the cause of this adverse event is the patient condition.The patient had a coronary artery bypass graft (cabg) about 10 years ago.Before the case the patient had very slow conduction and this was then proved when we got a long h-v as soon as catheters were placed in the body.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 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: 19150482
• MDR Text Key: 340673550
• Report Number: 2029046-2024-01318
• 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
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2024
• 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: 31229104L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/27/2024
• 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: CARTO 3 SYSTEM.; SMARTABLATE GENERATOR KIT-US.
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male