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

Catalog Number D132705

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

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

Event Date 12/06/2023

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.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrioventricular reentrant tachycardia/wolff-parkinson-white syndrome (avrt/wpw) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and there was barely any fluid coming out when flushed.It was reported that the ngen generator displayed a "high-temperature reading" when beginning ablation.To troubleshoot the staff tried to flush the catheter with barely any fluid coming out.The tubing was analyzed and was found to be fine.The tubing was disconnected from the catheter and fully flushed without resolution.The catheter was replaced, the issue was resolved, and the procedure was continued.There was no patient consequence.There was no issue with the pump.The issue was little to no flow coming from the ablation catheter.This was confirmed outside the body, after issue was discovered, as irrigation tubing was then disconnected from ablation catheter and tubing flowed fine indicating integrity of the pump and tubing was fine.Again, outside the body, the tubing was connected back to the catheter, and the pump set to high flow.Very little flow came out of the tip of the catheter, indicating catheter was not irrigating appropriately.

Manufacturer Narrative

It was reported that a patient underwent an atrioventricular reentrant tachycardia/wolff-parkinson-white syndrome (avrt/wpw) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and there was barely any fluid coming out when flushed.It was reported that the ngen generator displayed a "high-temperature reading" when beginning ablation.To troubleshoot the staff tried to flush the catheter with barely any fluid coming out.The tubing was analyzed and was found to be fine.The tubing was disconnected from the catheter and fully flushed without resolution.The catheter was replaced, the issue was resolved, and the procedure was continued.There was no patient consequence.There was no issue with the pump.The issue was little to no flow coming from the ablation catheter.This was confirmed outside the body, after issue was discovered, as irrigation tubing was then disconnected from ablation catheter and tubing flowed fine indicating integrity of the pump and tubing was fine.Again, outside the body, the tubing was connected back to the catheter, and the pump set to high flow.Very little flow came out of the tip of the catheter, indicating catheter was not irrigating appropriately.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, temperature, impedance, patency, and irrigation 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 the device was found working correctly.No temperature or impedance issues were observed.A patency and irrigation test were performed, and the device was flushing correctly.No obstructed holes were observed.No irrigation issues were observed.A manufacturing record evaluation (mre) was performed for the finished device number lot 31099278m and no internal action related to the complaint was found during the review.Based on the completed mre, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated with appropriate information.The issues 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.It should be noted that product failure is multifactorial.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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¿ 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: 18432378
• MDR Text Key: 331929458
• Report Number: 2029046-2024-00024
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D132705
• Device Lot Number: 31099278M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2023
• 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: NGEN RF GENERATOR.