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

Catalog Number D134804

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Sense (1559); Application Program Problem (2880)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the pebax with internal parts exposed.Initially it was reported that a magnetic sensor error (code unknown), as well as inaccurate force reading appeared on the carto 3 system when the thermocool® smart touch® sf bi-directional navigation catheter was in use and no point acquisition was possible with the catheter.The cable was exchanged without resolution.The catheter was exchanged and the error and issues resolved.The procedure continued successfully.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 02-feb-2024, there was reddish brown material inside and a hole on the pebax with internal parts exposed.This event was originally considered non-reportable, however, bwi became aware of a hole on the pebax with internal parts exposed on 02-feb-2024 and have assessed this returned condition as reportable.

Manufacturer Narrative

The device evaluation was completed on 02-feb-2024.The device was returned for evaluation, and visual inspection and screening tests of the returned device were performed following biosense webster (bwi) procedures.Visual analysis of the returned device revealed reddish brown material inside and a hole on the pebax with internal parts exposed; however, the hole could be related to the handling but, it cannot be conclusively determined.The magnetic and force feature was tested, and no errors were observed.The force values and the vector were observed within specifications.No force issues or black electrodes were observed.No malfunction was observed.The event described was unable to be duplicated during the product investigation; however, the blood inside the pebax area found could be related to the reported issue.The instructions for use (ifu) contain the following recommendations: the force or magnetic sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.A manufacturing record evaluation was performed for the finished device and no internal actions related to the reported complaint condition were identified.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: 18784717
• MDR Text Key: 336424087
• Report Number: 2029046-2024-00646
• Device Sequence Number: 1
• Product Code: LPB
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134804
• Device Lot Number: 31142940L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Date Manufacturer Received: 02/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2023
• 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: UNK CABLE; UNK_CARTO 3