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

Catalog Number D134805

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and observed clots on the catheter.During the procedure, when switching between catheters, the physician noticed clots on the ablation catheter.The catheter was replaced and the procedure ended successfully.There was no patient consequence.Additional information was received stating the clot was located on the tip electrode.The system did not present any error messages nor did the physician/user see any product problem.No issues related to temperature and flow on the catheter.The generator was set to power control mode, temperature cutoff 40 degrees, and power cutoff 40 w.The noted temperature was 28 degrees, power 40 w and impedance 130 ohm.The act was over 300 and it was maintained throughout all of the case.Used heparinized normal saline.The patient did not exhibit any neurological symptoms since the procedure was completed.The correct catheter settings were selected on the generator.The pump was switching from ¿low¿ to ¿high¿ flow during ablation.No issues with the pump.The duration of ablation used was not greater than 60 seconds.The force was normal, less than 25.The irrigation rate was not used outside of those prescribed.The pre-ablation high setting was 5 seconds.

Manufacturer Narrative

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 followup report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation (b)(6) 2024.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.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

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.During the procedure, when switching between catheters, the physician noticed clots on the ablation catheter.The catheter was replaced and the procedure ended successfully.There was no patient consequence.The device evaluation was completed on 29-feb-2024.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and temperature, impedance, and pump and pressure gage test of the returned device were performed following bwi procedures.Visual analysis revealed no thrombus residues in the tip of the device.The temperature, impedance, and pump and pressure gage tests were performed and the device was found working correctly.No temperature or irrigation issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendations: monitoring the temperature from the electrode during the application of radio frequency (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: 18592228
• MDR Text Key: 334835214
• Report Number: 2029046-2024-00311
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• 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: 31170187L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/27/2023
• 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: SMARTABLATE GENERATOR KIT-WW.; SMARTABLATE PUMP KIT-WW.; UNK_CARTO 3.