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); Incorrect, Inadequate or Imprecise Result or Readings (1535); Material Twisted/Bent (2981)

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

Event Date 01/10/2024

Event Type  malfunction  

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection, screening, temperature, impedance, and pressure gage test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed reddish material.Due to this condition, a scanning electron microscope report analysis (sem) was requested and a hole was discovered in the surface of the pebax.A temperature and impedance test was performed and no temperature issues were observed.The device was connected to carto 3 system, and the device was visualized and recognized correctly; however, error 106 appeared on the system due to an open circuit in the tip area.Afterward, a pump and pressure gage test was performed and an occlusion was detected.Further investigation revealed that reddish material was occluding the irrigation holes.A manufacturing record evaluation was performed for the finished device 31174474l number, and no internal actions related to the reported complaint condition were identified.The reddish material inside the pebax and in irrigation holes could be related to the force and temperature issues respectively 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).

Event Description

It was reported that a patient underwent an idiopathic deep vein thrombosis procedure with a thermocool® smart touch® sf bi-directional navigation catheter and post procedure the bwi product analysis lab identified a hole on the pebax.During the procedure, the catheter's temperature values displayed high on the smartablate® generator and carto® 3 system and an invalid temperature error was displayed when trying to go into ablation.The medical team checked the irrigation tubing and irrigation was fully functional.The physician also noticed that the catheter force value was also displaying high and they were unable to zero the catheter.The catheter showed around 23 grams of force all that time.The physician pulled the catheter out and noticed there was a kink two to three inches from the tip of the catheter.The catheter was replaced and the issue was resolved.The case continued.No patient consequences were reported.

• 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: 19013353
• MDR Text Key: 339286434
• Report Number: 2029046-2024-01081
• 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
• Report Date: 04/01/2024

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: 31174474L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2024
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2023
• 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.; SMARTABLATE GENERATOR.