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); Display or Visual Feedback Problem (1184); Obstruction of Flow (2423)

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

Event Date 02/01/2024

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation.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.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that during a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter there was an irrigation issue mid-ablation.The medical team discovered that instead of having irrigation in all directions, some holes weren't working.The nurses purged the tubing once, and once the catheter was outside of the patient's body, they purged it again.During these purges, the catheter issue was confirmed.The irrigation problem was discovered during shooting, which stopped the ablation.The procedural delay was approximately 10 minutes.No patient consequences were reported.

Manufacturer Narrative

The product investigation was completed.It was reported that during a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter there was an irrigation issue mid-ablation.The medical team discovered that instead of having irrigation in all directions, some holes weren't working.The nurses purged the tubing once, and once the catheter was outside of the patient's body, they purged it again.During these purges, the catheter issue was confirmed.The irrigation problem was discovered during shooting, which stopped the ablation.The procedural delay was approximately 10 minutes.No patient consequences were reported.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection and functional 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 were performed, and no issues were observed.Also, the device was connected to the carto 3 and the device was visualized correctly.In addition, an irrigation test was performed, and the device was irrigating correctly, the irrigation holes were not observed occluded, the irrigation umbrella was observed.A manufacturing record evaluation was performed for the finished device 31180103l number, and no internal actions related to the reported complaint condition were identified.The visualization, irrigation and temperature issues reported by the customer were not confirmed since the device was observed working correctly.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instruction for use (ifu) states: 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 radiofrequency (rf) 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.Do not use the catheter without irrigation flow.When rf energy is interrupted for either a temperature or an impedance rise (the set limit is exceeded), the catheter should be removed, and the tip cleaned of coagulum, if present.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: 19127598
• MDR Text Key: 340906526
• Report Number: 2029046-2024-01278
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031
• 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: 05/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 31180103L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/17/2024
• Supplement Dates Manufacturer Received: 04/18/2024; 04/22/2024
• Supplement Dates FDA Received: 04/18/2024; 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2023
• 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