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

Catalog Number D134805

Device Problems Obstruction of Flow (2423); High Readings (2459)

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

Event Date 02/09/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent a atrioventricular nodal reentrant tachycardia (avnrt) and atrial flutter ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and when the doctor was going to start the cavotricuspid ishmus (cti) there was a high impedance error on the ngen (unknown code).The medical team checked the catheter's connections but the issue persisted.The grounding pads were checked but the issue persisted.Additionally, there was an error on the irrigation pump (unknown code) and the pump would not flush.No irrigation flow was going through the thermocool smart touch catheter.The pump could not flush, the wheel stopped turning because the distal end of the catheter was clotted off inside the patient¿s body.The catheter was taken out and the catheter was "clotted." the catheter was on the low flow of 2 and would not flush.The medical team flushed the catheter with no resolution.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.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 a atrioventricular nodal reentrant tachycardia (avnrt) and atrial flutter ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and when the doctor was going to start the cavotricuspid ishmus (cti) there was a high impedance error on the ngen (unknown code).The medical team checked the catheter's connections but the issue persisted.The grounding pads were checked but the issue persisted.Additionally, there was an error on the irrigation pump (unknown code) and the pump would not flush.No irrigation flow was going through the thermocool smart touch catheter.The pump could not flush, the wheel stopped turning because the distal end of the catheter was clotted off inside the patient¿s body.The catheter was taken out and the catheter was "clotted." the catheter was on the low flow of 2 and would not flush.The medical team flushed the catheter with no resolution.The procedure continued.No patient consequences were reported.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, temperature, impedance, pump, and pressure gage 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 was performed and the device was found working correctly.No temperature or impedance issues were observed.However, during the pump and pressure gage test the device was found occluded.Further investigation revealed that the irrigation holes were occluded by reddish material.A manufacturing record evaluation was performed for the finished device number lot 31174348l and no internal action related to the complaint was found during the review.Since an occlusion was found in the irrigation holes, this failure could be related to the issues reported by the customer; therefore, the customer complaint was confirmed.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.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: 18832670
• MDR Text Key: 337312950
• Report Number: 2029046-2024-00717
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• 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: 31174348L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2023
• 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: 7FR DECAN,11P,F,2.4MMLE,282MM,; CARTO 3 SYSTEM (FOR JAPAN); NGEN PUMP, US CONFIGURATION