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); Insufficient Cooling (1130)

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

Event Date 03/12/2024

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 while the medical team was ablating, the temperature increased rapidly.The temperature exceeded the cut-off value of 42, within 1 second after starting ablation.The medical team also confirmed the presence of thrombus.The patient was anticoagulated throughout the case with an act (activated clotting time) of 300, which resulted in the tenth ablation.The correct catheter settings were selected on the generator.Normal saline was used to irrigate.The issue was not resolved by ablating on other location, dis-connecting and re-connecting and replacing the cable, or by checking the blood clots.The catheter was replaced and the procedure was completed without patient's consequence.

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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 24-apr-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 while the medical team was ablating, the temperature increased rapidly.The temperature exceeded the cut-off value of 42, within 1 second after starting ablation.The medical team also confirmed the presence of thrombus.The patient was anticoagulated throughout the case with an act (activated clotting time) of 300, which resulted in the tenth ablation.The correct catheter settings were selected on the generator.Normal saline was used to irrigate.The issue was not resolved by ablating on other location, dis-connecting and re-connecting and replacing the cable, or by checking the blood clots.The catheter was replaced and the procedure was completed without patient's consequence.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, temperature and impedance tests, and pump and pressure gauge test of the returned device were performed following bwi procedures.Visual analysis revealed corrosion in the connector area.To review the temperature and impedance features the handle was dissected and the continuity of the thermocouple wires was measured and no issues were observed.A pump and pressure gauge test were performed, and the device was irrigated correctly.No irrigation issues were observed.A manufacturing record evaluation was performed for the finished device number lot 31214975l and no internal action related to the complaint was found during the review.The thrombus/ clot and high temperature issues 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 potential cause of the corrosion could not be conclusively determined, as no water leakage was observed during the irrigation test, it was concluded that this issue may have occurred after the procedure.The instructions for use contain the following warnings and precautions that should be considered: when rf (radiofrequency) current is interrupted for either a temperature or an impedance rise (the set limit is exceeded), the catheter should be removed, and the tip cleaned.Make sure the irrigation holes are not plugged prior to re-insertion; do not immerse the handle or cable connector in fluids; electrical performance could be affected; the catheter is intended for use only with a compatible rf generator, a compatible irrigation pump, a carto¿ 3 system, biosense webster cables, and other appropriate interface cables and connectors.Use of a compatible irrigation pump is recommended to assure proper irrigation flow rate; the application of rf energy must not be initiated until the increase in irrigation flow rate is confirmed by a minimum of 2°c decrease in tip electrode temperature.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: 19061764
• MDR Text Key: 339878947
• Report Number: 2029046-2024-01155
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 31214975L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/12/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/24/2024
• Supplement Dates FDA Received: 05/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2024
• 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.