MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133604IL

Device Problem Obstruction of Flow (2423)

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent a pvc procedure with a thermocool® smart touch¿ electrophysiology catheter and an irrigation issue occurred during use on the patient.Occlusion/ no irrigation.During the procedure, device (including port, luer hub) was not irrigating.A second device was used to complete the procedure.There was no adverse event reported on the patient.Additional information was received on 15-mar-2024.The suspected device for the reported flow/irrigation issue was the catheter.The issue was noted during or after the device was used on the patient.No error was noted from the irrigation pump.The issue was discovered by the pump tube connected to the catheter walking 2ml irrigation pump did not walk, they removed the catheter walked normally, and the discharge temperature showed.They replaced the catheter to resolve the irrigation tubing.The correct catheter settings were selected on the generator.The pump was not switching from ¿low¿ to ¿high¿ flow during ablation.Additional information was received on 26-mar-2024.The generator was on automatic mode.The generator and the pump did not provide an error message.During high flow ablation, ¿high temperature¿ alert screen displayed by generator.Unable to confirm if the generator continued ablation.No servicing was needed on the generator and the pump.Clarification was received on previous response stating that the issue was noted during the device used on the patient and the pump was switching from ¿low¿ to ¿high¿ flow during ablation.Additional information was received on 07-apr-2024.The system stopped ablation when any of the cut off values were exceeded.It will not ablate.The generator parameters were power control mode; cut off 45; power cut off 35w.The high temperature alert screen displayed was assessed as not mdr reportable.The most likely consequence was an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.The irrigation issue was originally considered non-reportable, however, bwi became aware that the irrigation issue was noted during use on the patient on (b)(6) 2024 and have reassessed the event as reportable.The awareness date for this record is 15-mar-2024.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on (b)(6) 2024.The device evaluation was completed on (b)(6) 2024.The device was returned to biosense webster for evaluation.A visual inspection, pump and pressure gage test of the returned device were performed in accordance with bwi procedures.Visual analysis revealed no damage or anomalies on the device.A pump and pressure gage test was performed, and the catheter failed the test since the irrigation tube was found folded at the tip section.A manufacturing record evaluation was performed and no internal actions related to the reported complaint condition were identified.The irrigation issue reported by the customer was confirmed.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.Do not manually pre-shape the distal shaft of the catheter by applying external forces intended to bend or affect the intended shape or curve of the catheter.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.Manufacturer¿s reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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: 19094243
• MDR Text Key: 340573740
• Report Number: 2029046-2024-01206
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/11/2024

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: D133604IL
• Device Lot Number: 31199645M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/02/2024
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/05/2023
• 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: SMARTABLATE GENERATOR KIT (CN).; SMARTABLATE PUMP KIT (CN).