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); Obstruction of Flow (2423)

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

Event Date 12/29/2023

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 a pulmonary vein isolation (pvi) and cavotricuspid ishmus (cti) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the catheter would not flush properly during ablation.It was initially reported that the catheter would not flush properly and a high-temperature error appeared on the generator.The caller checked the connections but the issue persisted.The caller checked the tubing but the issue persisted.When the catheter was replaced, the issue was resolved.On 4-jan-2024, additional information was received indicating the issue was noticed during ablation in the cti portion of the ablation; pvi was already performed without issue.There was no error on the pump, temperature would immediately go above limit when ablation is started.They checked to make sure tubing is attached to the catheter, checked to make sure pump is able to go into high flow, reseated tubing in the pump rollers, changed catheter.Correct settings were selected on the generator and the pump was switching from ¿low¿ to ¿high¿ flow during ablation.

Manufacturer Narrative

It was reported that a patient underwent a pulmonary vein isolation (pvi) and cavotricuspid ishmus (cti) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the catheter would not flush properly during ablation.It was initially reported that the catheter would not flush properly and a high-temperature error appeared on the generator.The caller checked the connections but the issue persisted.The caller checked the tubing but the issue persisted.When the catheter was replaced, the issue was resolved.On 4-jan-2024, additional information was received indicating the issue was noticed during ablation in the cti portion of the ablation; pvi was already performed without issue.Device investigation details: an analysis of the product could not be performed since a physical sample was not received for evaluation.However, if the product is received at a later date, the investigation will be updated as applicable.A manufacturing record evaluation was performed for the finished device number lot 31170749l and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 18587253
• MDR Text Key: 333844693
• Report Number: 2029046-2024-00300
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• 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: 31170749L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/11/2023
• 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: UNK GENERATOR; UNK PUMP