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

Catalog Number D134805

Device Problems Insufficient Cooling (1130); Device Contamination with Body Fluid (2317); Material Protrusion/Extrusion (2979)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2024

Event Type  malfunction  

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 reference number: (b)(4).

Event Description

It was reported that a patient underwent an ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the medical team noticed high temperature readings on the generator.The ablation shut off automatically due to the high temperature readings.The catheter and generator settings were correct.There were no issues with the irrigational flow.The physician took the catheter out and there was visible char on the electrode's tip, though they did not consider the amount of char as a patient risk.The physician also noted that the shaft of the catheter was kinked and internal pieces of the catheter were exposed.The catheter was replaced and the procedure continued without the aforementioned issues.No patient consequences were reported.

Manufacturer Narrative

On 1-mar-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 ischemic ventricular tachycardia (isvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the medical team noticed high temperature readings on the generator.The ablation shut off automatically due to the high temperature readings.The catheter and generator settings were correct.There were no issues with the irrigational flow.The physician took the catheter out and there was visible char on the electrode's tip, though they did not consider the amount of char as a patient risk.The physician also noted that the shaft of the catheter was kinked and internal pieces of the catheter were exposed.The catheter was replaced and the procedure continued without the aforementioned issues.No patient consequences were reported.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, temperature, impedance, pump and pressure gage test of the returned device were performed following bwi procedures.Visual analysis revealed char residues and broken shaft with internal components exposed close to the handle.The temperature and impedance test was performed and the device was found working correctly.No temperature or impedance issues were observed.However, during the irrigation test water leakage was detected coming through the broken shaft, for this reason, the test could not be completed correctly.A manufacturing record evaluation was performed for the finished device number lot 31185753l and no internal action related to the complaint was found during the review.Since char and water leakage was found, the issues reported by the customer were confirmed.Char is a physical phenomenon of rf (radiofrequency), it can be the normal result of the ablation process.The potential cause of the broken shaft could be related to the excessive force or manipulation of the device during the procedure; however, this can not be conclusively determined.It should be noted that product failure is multifactorial.The instructions for use contain the following recommendations: monitoring the temperature from the electrode during the application of rf current ensures that the irrigation flow rate is being maintained.Using tip temperature to guide ablation could result in deeper lesions and increased risk for collateral damage.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: 18799676
• MDR Text Key: 336516365
• Report Number: 2029046-2024-00665
• Device Sequence Number: 1
• Product Code: LPB
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 03/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31185753L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2023
• 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: AGILIS MEDIUM CURL, 8.5 FRENCH SHEATH; CARTO 3 SYSTEM WITH VISITAG; SMARTABLATE GENERATOR; UNSPECIFIED PUMP