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

Model Number D134805

Device Problems Display or Visual Feedback Problem (1184); Contamination /Decontamination Problem (2895)

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

Event Date 07/14/2022

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.Initially, it was reported that the catheter image displayed as if it was touching another catheter.They tried to re-zero the catheter several times and the issue persisted.The cable was exchanged, and the issue persisted.The catheter was exchanged, and the issue was resolved, and the case continued.No adverse patient consequences were reported.The visualization issue was assessed as not mdr reportable.The potential risk that it could cause or contribute to a serious injury or death is remote.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found 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 on (b)(6) 2022.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device on 04-aug-2022.The device evaluation was completed on 09-aug-2022.The device was returned to bwi for evaluation.Bwi conducted a visual inspection and failure analysis on the returned device.Visual analysis of the returned sample revealed a cut on 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.The catheter was connected to the carto 3 system and it was recognized.However, error 106 appeared on the system due to an open circuit on the tip area.The evaluation determined that the cause of pebax damage failure cannot be established.However, the blood found inside the pebax area may have contributed to the 106-error displayed on the carto 3 system.A manufacturing record evaluation was performed for the finished device 30781306l number, and no internal actions related to the complaint were found during the review.It should be noted that product failure is multifactorial.The instructions for use contain the following warning stated in the carto 3 system manual: for magnetic issues, the catheter is disconnected.To continue, replace the catheter cable.If that does not resolve the problem, replace the catheter.As part of bwi¿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 4.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15366523
• MDR Text Key: 305622186
• Report Number: 2029046-2022-02123
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30781306L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2022
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2022
• 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: CARTO 3 SYSTEM; UNK BRAND CABLE; UNK BRAND CATHETER