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

Model Number D134805

Device Problems Insufficient Cooling (1130); Contamination /Decontamination Problem (2895)

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

Event Date 11/05/2021

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster inc, (bwi) product analysis lab observed a cut on the pebax.Initially, it was reported that when trying to ablate using the smartablate system, a rapid elevation of temperature beyond 40 degrees celsius was observed.This occurred in the middle of the surgery, after having made the electro-anatomical map of the right outflow tract, and after having performed the first ablation of approximately 20 seconds in an area of interest.Therefore, the system stopped the ablation, then this continued to happen several more times.Therefore, the smartablate system was restarted, ¿the catheter is flashed outside the patient¿, the connector is checked, but ¿everything continued equal¿.Then later, it was decided to change the catheter and the problem was solved.There was a 10-minute delay due to the reported event.No adverse patient consequences were reported.The high temperature cut-off exceeded was assessed as not mdr reportable.Since the generator stopped delivering radiofrequency (rf), the most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and visual analysis of the returned sample revealed a cut on the pebax with reddish-brown material inside and internal parts exposed.This finding was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is (b)(6) 2022.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device on 01-jul-2022.The device evaluation was completed on 06-aug-2022.Visual inspection, as well as temperature and impedance test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed a cut on the pebax with reddish-brown material inside and internal parts exposed; however, the cut could be related to the handling since in the process there are control inspection points to avoid this kind of issue.A temperature, impedance and flow test were performed, and the device was found working correctly.No temperature or impedance issues were observed.A manufacturing record evaluation was performed for the finished device 30494801l number, and no internal actions related to the complaint were found during the review.The issue reported by the customer could not be replicated during the product investigation.The blood inside the pebax could be related to the issue reported by the customer; however, this cannot be conclusively determined.The (ifu) instructions for use contain the following recommendations: if temperature increases to 40°c during rf energy delivery, power delivery should be interrupted.The irrigation system must be rechecked prior to restarting rf delivery.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15339258
• MDR Text Key: 305686954
• Report Number: 2029046-2022-02078
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2022

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 Expiration Date: 02/01/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30494801L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/06/2022
• Initial Date FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2021
• 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: UNK BRAND CATHETER; UNK_SMARTABLATE GENERATOR