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

Catalog Number D134804

Device Problems Coagulation in Device or Device Ingredient (1096); Improper or Incorrect Procedure or Method (2017)

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

Event Date 12/05/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the pump was not starting up on the first ablation.The incorrect catheter was selected on the generator so the pump didn¿t start up.The power setting was 40 watts and the temperature control mode was selected for the 4 mm catheter--which was an accidental selection.The medical team took out the catheter to flush it, and when they moved the catheter from the body there was a blood-type substance below the tip of the catheter.The blood-type substance couldn't be removed.The activated clotting time (act) was 300 plus.The irrigation settings used were not outside of the proper parameters.Heparinized normal saline was used as the irrigation fluid.No system error messages occurred during the event.The catheter was replaced and 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 5-jan-2024, the product investigation was completed as the complaint device was not returned.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 31151877l number, and no internal action related to the complaint was found during the review.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 (b)(6)2024, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the pump was not starting up on the first ablation.The incorrect catheter was selected on the generator so the pump didn¿t start up.The power setting was 40 watts and the temperature control mode was selected for the 4 mm catheter--which was an accidental selection.The medical team took out the catheter to flush it, and when they moved the catheter from the body there was a blood-type substance below the tip of the catheter.The blood-type substance couldn't be removed.The activated clotting time (act) was 300 plus.The irrigation settings used were not outside of the proper parameters.Heparinized normal saline was used as the irrigation fluid.No system error messages occurred during the event.The catheter was replaced and the procedure continued.No patient consequences were reported.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, temperature and impedance, and pump and pressure gage test of the returned device were performed following bwi procedures.Visual analysis revealed reddish material and a hole in the surface of the pebax.The temperature, impedance, pump and pressure gage test was performed and the device was found working correctly.No temperature, impedance or irrigation issues were observed.A manufacturing record evaluation was performed for the finished device 31151877l number, and no internal action related to the complaint was found during the review.The reddish material inside the pebax could be related to the thrombus/clot issue reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the damage on the pebax could be related to the usage of the device during the procedure; however, this cannot be conclusively determined.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: pc-(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: 18423815
• MDR Text Key: 332608999
• Report Number: 2029046-2024-00013
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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,Followup
• Report Date: 03/18/2024

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: D134804
• Device Lot Number: 31151877L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2023
• 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 WITH VISITAG.; SMARTABLATE PUMP.