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

Catalog Number D134805

Device Problems Coagulation in Device or Device Ingredient (1096); High Readings (2459)

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

Event Date 01/30/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the ¿temp high¿ alert was displayed at the time of using the foot pedal.It was the second ablation procedure.At the time of the first ablation of the right gap after ablating the left gap.The medical team considered the impedance to be slightly elevated.The activated clotting time (act) was 232.When smart touch sf catheter was removed from the patient¿s body, there was no problems at the tip of the catheter, but blood clot was observed when blood was removed from vizigo sheath.There were no problems of irrigation when checking.Then, the foot pedal was used, and the issue occurred again.It was resolved by replacing the stsf catheter with another new one.There was no reproducibility of the issue.There were no problems related to temperature, resistance value, or irrigation.Ablation time did not exceed 60 seconds (per ablation).Ablation time did not exceed 120 seconds (per ablation).The patient had no consequences observed until leaving the room.Total ablation time was about 10 minutes.There was no clot attached to the electrodes of the catheter.No patient consequences were reported.

Manufacturer Narrative

E1 initial reporter phone: (b)(6).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 12-mar-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 ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the ¿temp high¿ alert was displayed at the time of using the foot pedal.It was the second ablation procedure.At the time of the first ablation of the right gap after ablating the left gap.The medical team considered the impedance to be slightly elevated.The activated clotting time (act) was 232.When smart touch sf catheter was removed from the patient¿s body, there was no problems at the tip of the catheter, but blood clot was observed when blood was removed from vizigo sheath.There were no problems of irrigation when checking.Then, the foot pedal was used, and the issue occurred again.It was resolved by replacing the stsf catheter with another new one.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, temperature, impedance, pump, and pressure gauge test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.No char, thrombus or clot residues were observed during the inspection.The temperature and impedance test was performed and the device was found working correctly.No temperature or impedance issues were observed.A pump and pressure gauge test were performed, and the device was irrigating correctly.No irrigation issues were observed.A manufacturing record evaluation was performed for the finished device number lot 31173535l and no internal action related to the complaint was 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 recommendations: if the radiofrequency (rf) generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.Flush the catheter with heparinized saline before insertion into the body.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: 18753337
• MDR Text Key: 336966733
• Report Number: 2029046-2024-00577
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2024
• 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: 31173535L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2023
• 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; VIZIGO SHEATH
• Patient Age: 70 YR
• Patient Sex: Male