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

Catalog Number D134805

Device Problem Obstruction of Flow (2423)

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

Event Date 02/15/2024

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter address was not provided.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 a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the catheter temperature increased quickly when physician started to deliver first ablation radio frequency.After reviewing the irrigation, the physician realized that pores of ablation catheter were blocked and he wasn't able to unblocked with a purge of the irrigation system.It was during the first ablation, so the purging was not possible due to charring.The physician determined that the amount of charring did not present a patient risk.There were no error messages noted.The patient was properly anti-coagulated.The activated clotting time (act) was 300-350.The procedure was successfully completed.No patient consequences were reported.

Manufacturer Narrative

On 2-apr-2024, the product investigation was completed.It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the catheter temperature increased quickly when physician started to deliver first ablation radio frequency.After reviewing the irrigation, the physician realized that pores of ablation catheter were blocked and he wasn't able to unblocked with a purge of the irrigation system.It was during the first ablation, so the purging was not possible due to charring.The physician determined that the amount of charring did not present a patient risk.There were no error messages noted.The patient was properly anti-coagulated.The activated clotting time (act) was 300-350.The procedure was successfully completed.No patient consequences were reported.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, patency and irrigation test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.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 was performed for the finished device number lot 31180201l and no internal actions related to the complaint were found during the review.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 warning and precautions: purge the catheter and the irrigation tubing with heparinized normal saline prior to insertion of the catheter into the patient.Inspect the irrigation saline for air bubbles prior to its use in the procedure.Air bubbles in the irrigation saline may cause emboli.Always maintain a constant heparinized normal saline infusion to prevent coagulation within the lumen of the catheter.Do not use the catheter without irrigation flow.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: 18905164
• MDR Text Key: 337688243
• Report Number: 2029046-2024-00836
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• 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: 31180201L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2024
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2023
• 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 GENERATOR; SMARTABLATE PUMP