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

Model Number D134804

Device Problem Failure to Sense (1559)

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

Event Date 02/23/2023

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 reddish-brown material inside and a hole on the pebax with internal parts exposed.Initially, it was reported that a thermocool smarttouch® sf catheter had a catheter force sensor error (error#106) displayed on the carto® 3 system.The cable was replaced without resolution.The catheter was replaced, and the issue was resolved, and the case continued.No adverse patient consequences were reported.The force sensor error 106 was assessed as not mdr reportable.The potential risk that it could cause or contribute to a death or serious deterioration in state of health is remote.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found on 03-may-2023 that there was a reddish-brown material inside and a hole on the pebax with internal parts exposed.This finding was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is 03-may-2023.

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device on 13-apr-2023.The device evaluation was completed on 03-may-2023.A visual inspection and screening tests were performed following bwi procedures.Visual analysis of the returned device revealed reddish brown material inside and a hole on the pebax with internal parts exposed.The force feature was tested, and no errors were observed.The force values and the vector were observed within specifications.No malfunction was observed.The events described were 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 contain the following information that should be considered: to ensure accurate force readings, verify that the force reading is near zero when the catheter is not in contact with the tissue.If the force reading is not near zero when the catheter is not in contact with tissue, perform zeroing.A manufacturing record evaluation was performed for the finished device 30940921l number, and no internal actions related to the complaint were found during the review.Biosense webster¿s quality process ensures 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).

• 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: 17022890
• MDR Text Key: 317174775
• Report Number: 2029046-2023-01171
• 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: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2023
• 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: 30940921L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2023
• Date Manufacturer Received: 05/03/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2022
• 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: SMA SCOM RECORD/CARTO CABLE 5M; SMARTABLATE GENERATOR KIT-US; THMCL SMTCH SF BID, TC, F-J; UNIK BRAND CABLE; UNK BRAND CABLE