MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D133601

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 11/10/2022

Event Type  malfunction  

Event Description

It was reported that an unknown underwent an unknown ablation procedure with a thermocool® smart touch¿ electrophysiology catheter.There were reports of charring on two characters.No patient consequences were reported.The char/coagulum/thrombus/clot was located between electrodes.No error messages or did the physician/user see any product problem.There were no issues related to temperature and flow on the catheter, but without any explainable reason, an impedance rise was noticed, several times after ai already was over 400.Temp cut off 50 degrees.Act was maintained throughout the case at act<300.Generator information was smartablate, g4c-3154.Pump information was pump g4cp-3185.Charring occurred on two catheters.It happened in same patient.The patient had an extremely high blood count, (hb 190 g/l).So probably may be the reason for charring issue! patient did not exhibit any neurological symptoms since the procedure was completed.Physician considered that the char /coagulum/thrombus/clot was moderate, charring does not occur often so difficult question.Physician considered the amount of char/ coagulum/ thrombus/clot observed caused a potential risk to this patient because there is a risk of stroke, but no adverse event occurred.Correct catheter settings was selected on the generator.Pump switching was from ¿low¿ to ¿high¿ flow during ablation.The duration of ablation used was not greater than 60 seconds or greater than 120 seconds.There were no ablations that used forced above 40 g for any extended periods of time.Irrigation rate was not used outside of those prescribed.Normal saline was used as the irrigation fluid.Settings for the carto visitag module used was respiration setting , stability range3, stability time3, force over time3, & tag size 2 mm.Color options used prospectively was tag index.The impedance rose when ai got over 400, so the physician could ablate to ai 400 and finish the or.Thrombus/clot is mdr-reportable.Biosense webster manufacturer's reference number (b)(4) has 2 reports since the issue occurred on 2 catheters.

Manufacturer Narrative

Initial reporter phone: (b)(6).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).

Manufacturer Narrative

On 24-apr-2023, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that an unknown underwent an unknown ablation procedure with a thermocool® smart touch¿ electrophysiology catheter.There were reports of charring on two characters.No patient consequences were reported.Device evaluation details: visual inspection revealed no damage or anomalies on the device, no char/coagulum/thrombus/clot residues were observed.A temperature, impedance and cool flow pump and gage test were performed and the results were found within the specifications.No temperature, impedance, or flow issues were observed.A manufacturing record evaluation was performed for the finished device 30882076m number, and no internal actions related to the reported complaint condition 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 stated in the carto 3 system manual: char is a physical phenomenon of rf, it can be the normal result of the ablation process.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¿ ELECTROPHYSIOLOGY 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: 15980694
• MDR Text Key: 308306133
• Report Number: 2029046-2022-03112
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D133601
• Device Catalogue Number: D133601
• Device Lot Number: 30882076M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2022
• 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.; CARTO VISITAG MODULE.; SMARTABLATE GENERATOR.; SMARTABLATE PUMP.