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

Catalog Number D134804

Device Problems Coagulation in Device or Device Ingredient (1096); Device Contamination with Body Fluid (2317); Obstruction of Flow (2423)

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

Event Date 12/21/2023

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.(b)(4).

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 during ablation the physician requested to check for char.The character was removed and a lot of char was found.When the medical team attempted to flush the catheter they found that they were unable to flush the catheter freely.The patient was anticoagulated and their activated clotting time was within the proper therapeutic range.The generator and pump settings were appropriate.However, the result was char that the physician deemed to be excessive.The physician did confirm that heparinized normal saline was not used as the irrigation fluid.The physician requested a new catheter.Upon replacing the catheter the issue was resolved and the procedure continued.

Manufacturer Narrative

On 24-jan-2024, the product investigation was completed as the device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31165621l and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 20-feb-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 during ablation the physician requested to check for char.The character was removed and a lot of char was found.When the medical team attempted to flush the catheter they found that they were unable to flush the catheter freely.The patient was anticoagulated and their activated clotting time was within the proper therapeutic range.The generator and pump settings were appropriate.However, the result was char that the physician deemed to be excessive.The physician did confirm that heparinized normal saline was not used as the irrigation fluid.The physician requested a new catheter.Upon replacing the catheter the issue was resolved and the procedure continued.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection, flow pump, and temperature and impedance tests of the returned device were performed in accordance with bwi procedures.Visual analysis of the returned device revealed that no damage or anomalies were observed on the device, however, char attached to the tip of the device was found and some irrigation holes were blocked with reddish material.Temperature and impedance test was performed, and the device was found working correctly.No temperature or impedance issues were observed.A flow pump and pressure gage test was performed, and the device was irrigating correctly.No irrigation issues were observed.Despite the results of the irrigation test, it was determined that the irrigation feature was compromised due to the blockage of the irrigation holes with reddish material a manufacturing record evaluation was performed for the finished device number lot 31165621l and no internal action related to the complaint was found during the review.The issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.The evaluation determined that char is a physical phenomenon of rf (radiofrequency), it can be the normal result of the ablation process.The instructions for use contain the following guideline: 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.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: 18545308
• MDR Text Key: 333504876
• Report Number: 2029046-2024-00240
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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,Followup
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134804
• Device Lot Number: 31165621L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2023
• 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: CARTO 3 SYSTEM WITH VISITAG; THMCL SMTCH SF BID, TC, F-J