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

Catalog Number D134804

Device Problems Insufficient Cooling (1130); Obstruction of Flow (2423)

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

Event Date 01/29/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent a right-sided atrial flutter ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and on ablation the catheter was not irrigating and there a "high temperature" error and readings appeared on the carto 3 system.The irrigation tubing was reseated but the issue was not resolved.The medical team flushed the catheter but the issue persisted.The tip of the catheter was inspected but there was no visible physical damage or char noted.However, the irrigation issue persisted.The irrigation tubing, ngen pump, and saline bag were inspected and no issues were found.There were no air bubbles, leaks, or improperly connected components.The suspected issue was with the catheter.The pump was working well with no issues.The error resolved by replacing the catheter.The procedure continued.No patient consequences were reported.

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).

Manufacturer Narrative

On 10-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 a right-sided atrial flutter ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and on ablation the catheter was not irrigating and there a "high temperature" error and readings appeared on the carto 3 system.The irrigation tubing was reseated but the issue was not resolved.The medical team flushed the catheter but the issue persisted.The tip of the catheter was inspected but there was no visible physical damage or char noted.However, the irrigation issue persisted.The irrigation tubing, ngen pump, and saline bag were inspected and no issues were found.There were no air bubbles, leaks, or improperly connected components.The suspected issue was with the catheter.The pump was working well with no issues.The error resolved by replacing the catheter.The procedure continued.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 no damage or anomalies on the device.The temperature and impedance test was performed and the device was found working correctly.No temperature issues were observed.Afterward, a pump and pressure gage test was performed and the device was found occluded.Further investigation revealed that a reddish material and a white material were occluding the irrigation holes.An energy dispersive spectroscopy (eds) analysis was requested since a white foreign material was observed in the irrigation holes.It was determined that there was evidence of saline solution and human tissue or fluid.A manufacturing record evaluation was performed for the finished device number lot 31151821l and no internal action related to the complaint was found during the review.The human tissue and saline solution observed occluding the irrigation holes in the dome area could be related to the irrigation and high-temperature issue reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the human tissue and saline solution residues on the dome cannot be determined.The instructions for use contain the following recommendations: do not use the temperature sensor to monitor tissue temperature or to guide power titration during ablation.The temperature sensor located within the tip section of the catheter does not reflect either electrode-tissue interface or tissue temperature due to the cooling effects of the saline irrigation of the electrode.The temperature displayed on the rf generator is the temperature of the cooled electrode, not tissue temperature.The temperature sensor is used to verify that the irrigation flow rate is adequate.Before initiating the application of rf (radiofrequency) energy, a decrease in electrode temperature confirms the onset of saline irrigation of the ablation electrode.Monitoring the temperature from the electrode during the application of rf energy 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: 18744139
• MDR Text Key: 335846987
• Report Number: 2029046-2024-00553
• 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: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2024
• 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: 31151821L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/03/2023
• 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; NGEN PUMP