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

Catalog Number D134804

Device Problems Signal Artifact/Noise (1036); Electrical Shorting (2926)

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

Event Date 12/08/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation, visual inspection and electrical tests of the returned device were performed following biosense webster (bwi) procedures.Visual analysis of the returned device revealed a hole in the pebax with internal parts exposed.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly.There were no current leakage issues observed.An electrical test was performed, and an open circuit was found on the tip area.The issues reported by the customer could not be replicated during the product investigation; however, the hole in the pebax area could be related to the reported issue as a potential cause.The instructions for use contain the following recommendation: the current leakage disconnects the body surface ecg cable and all catheter extension cables from the piu.If the problem persists, replace the catheter cable or the catheter.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.A manufacturing record evaluation was performed for the finished device 31142857l number, and no internal actions related to the complaint were found during the review.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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).

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax with internal parts exposed.Initially, it was reported that the carto 3 system displayed error 7 (current leakage error) when the catheter was connected to the patient interface unit.There was also a signal interference (signal loss) observed on the body surface (bs) and intracardiac (ic) echocardiogram (ecg).There was an ecg signal on the anesthesia monitor available to the physician.To troubleshoot, the cable was replaced without resolution.When the catheter was replaced, the issue was resolved, and the procedure was continued.No adverse patient consequence was reported.The current leakage and signal noise issues were assessed as non mdr reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 06-feb-2024, there was a hole in the pebax with internal parts exposed.The hole in the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 06-feb-2024.

• 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: 18814446
• MDR Text Key: 336877777
• Report Number: 2029046-2024-00694
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2024
• 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: 31142857L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2024
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/29/2023
• 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 BRAND CABLE; UNK BRAND CABLE; UNK_CARTO 3