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

Model Number D134804

Device Problem Signal Artifact/Noise (1036)

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

Event Date 03/10/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) 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 with reddish-brown material inside and internal parts exposed.Initially, it was reported, that during the procedure, there was noise on the distal electrodes 1 and 2 on both the carto 3 system and the recording system.To troubleshoot, the cable was replaced without resolution.The catheter was replaced, the issue was resolved, and the procedure was continued.No adverse patient consequences were reported.The bad/partial ecg was assessed as not mdr reportable.The risk to the patient is low.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found on 05-apr-2023 that there was 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 05-apr-2023.

Manufacturer Narrative

The biosense webster, inc.(bwi) product analysis lab received the device on 27-mar-2023.The device evaluation was completed on 05-apr-2023.A visual inspection and electrical tests were performed on the returned device.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.An electrical test was performed, in accordance with bwi procedures.Current leakage was observed and the potential failure of the current leakage could be related to the damage on pebax.However, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 30960948l number, and no internal action was found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use contain the following warning stated in the carto 3 system manual: ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.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.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.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: 16857665
• MDR Text Key: 314454010
• Report Number: 2029046-2023-00939
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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: 05/02/2023

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 Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30960948L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2023
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 05/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2022
• 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: THMCL SMTCH SF BID, TC, F-J.; UNK BRAND CABLE.; UNK BRAND CABLE.