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

Catalog Number D132705

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 10/10/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a procedure with a thermocool® smart touch¿ bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax with exposure to internal components.The thermocool® smart touch¿ bi-directional navigation catheter force readings were erroneous.Force was showing as very low (0g-3g) even though the operator believed they were in contact with the tissue.As soon as an ablation was started, the force readings would jump up to 60g/70g with the same catheter position.Ablation catheter was being used with vizigo sheath in the left atrium.Issue was resolved by changing the catheter cable, while they also moved the x-ray further out of the way, and unplugged the signal processing unit (spu) via 20a/20b cables being removed from the patient interface unit (piu).The procedure was completed with minimal delay with no impact on the treatment received by the patient.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 10-jan-2024, they observed a hole in the pebax with exposure to internal components and traces of blood.This event was originally considered non-reportable, however, bwi became aware of a hole in the pebax with exposure to internal components on 10-jan-2024 and have assessed this returned condition as reportable.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 28-nov-2023.The device evaluation was completed on 10-jan-2024.The device was returned to biosense webster (bwi) for evaluation.The returned device's visual inspection and screening test were performed following bwi procedures.Visual analysis revealed a hole in the pebax with exposure to internal components and traces of blood.The root cause of the damage could be related to improper handling; however, this cannot be conclusively determined.The device was connected to the carto 3 system, and although it was recognized and visualized correctly, hi force appeared due to the pebax condition.This issue could be attributed to the issue reported.The force issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: the force 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 action was found during the review.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).

Manufacturer Narrative

Additional information was received on 15-feb-2024 clarifying that the catheter was not replaced and no additional issue with the returned catheter.In addition, confirmed that the issue was resolved with a new cable.The case was completed after changing the cable.The cable is not available for return from the customer.Therefore, since it was confirmed that the issue was resolved with the changing of the cable and there were no additional issues with the returned catheter, updated the h6.Medical device problem code from ¿incorrect, inadequate or imprecise result or readings (a0908)¿ to ¿adverse event without identified device or use problem (a24)¿.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¿ 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: 18678745
• MDR Text Key: 335032502
• Report Number: 2029046-2024-00447
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 03/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D132705
• Device Lot Number: 31084161M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2023
• 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 CATHETER CABLE.; UNK_CARTO 3.; UNK_CARTO VIZIGO SHEATH.