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

Model Number D134805

Device Problems Failure to Sense (1559); Patient Device Interaction Problem (4001)

Patient Problem Tachycardia (2095)

Event Date 10/17/2022

Event Type  Injury  

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).

Event Description

It was reported that a patient undergoing an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient had a ventricular ectopy arrhythmia.The patient had an atrial fibrillation (af) arrhythmia, then started an arrhythmia of ventricular ectopy.The adverse event occurred intraoperative procedure.This complaint will conservatively be reported for ventricular tachycardia as an arrhythmia of ventricular ectopy was reported.The physician¿s opinion on the cause of this adverse event was that the thermocool® smart touch® sf bi-directional navigation catheter failed in the force sensor.However, additional follow is being performed requesting clarification to which type of arrhythmia of ventricular ectopy the patient experienced and to confirm if it was believed to be due to malfunction.The patient did not require extended hospitalization because of the adverse event.Should additional information become available this complaint will be reassessed accordingly.It was also reported there were no patient consequences and no need for additional procedures.The thermocool® smart touch® sf bi-directional navigation catheter failed in the force sensor, causing code 106 error in the carto 3 system.An attempt was made to replace the connector, but without success.After replacing the catheter, the procedure can be successfully completed.There was no generation of fragments or consequences for the patient due to this issue.This issue itself ss not considered to be mdr reportable since the potential risk that it could cause or contribute to a death or serious deterioration in state of health is remote.

Manufacturer Narrative

On 6-dec-2022, 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).

Manufacturer Narrative

It was reported that a patient undergoing an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient had a ventricular ectopy arrhythmia.The patient had an atrial fibrillation (af) arrhythmia, then started an arrhythmia of ventricular ectopy.The adverse event occurred intraoperative procedure.This complaint will conservatively be reported for ventricular tachycardia as an arrhythmia of ventricular ectopy was reported.The physician¿s opinion on the cause of this adverse event was that the thermocool® smart touch® sf bi-directional navigation catheter failed in the force sensor.However, additional follow is being performed requesting clarification to which type of arrhythmia of ventricular ectopy the patient experienced and to confirm if it was believed to be due to malfunction.The patient did not require extended hospitalization because of the adverse event.The thermocool® smart touch® sf bi-directional navigation catheter failed in the force sensor, causing code 106 error in the carto 3 system.An attempt was made to replace the connector, but without success.After replacing the catheter, the procedure can be successfully completed.Attempts were made to obtain clarification to this complaint.However, no further information has been made available.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a general inspection through the visual inspection and all features of the catheter tests.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the catheter.Per the event, several tests were performed.The magnetic, temperature features were tested, and no issues were observed.In addition, the product was deflecting and irrigating correctly.The force issue reported by the customer was confirmed.The screening test was performed on carto, and the device failed.Error 106 was observed.The device was dissected on the tip area; loss of electrical continuity at the sensor was found, it was determined that the root cause was an internal failure of the sensor.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the customer¿s reported force sensor error.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer's reported adverse event.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: 15802630
• MDR Text Key: 303702113
• Report Number: 2029046-2022-02834
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30712141L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2022
• 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: CARTO 3 SYSTEM.
• Patient Outcome(s): Life Threatening