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

Catalog Number D134721IL

Device Problem Signal Artifact/Noise (1036)

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

Event Date 01/20/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® smart touch® sf uni-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax.Initially, it was reported that during the operation, a signal interference noise was observed on intracardiac (ic) channels.A second device was used to complete the operation.There was no adverse event reported on patient.The signal noise issue was 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 (b)(6) 2024, there was reddish material inside the pebax and a hole in its surface.The hole in the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was (b)(6) 2024.

Manufacturer Narrative

The product was returned to biosense webster (bwi) for evaluation.A visual inspection and electrical evaluation of the returned device were performed following bwi procedures.Visual analysis revealed reddish material inside the pebax and a hole in its surface.An electrical test was performed, and an open circuit was found on the shaft area.A manufacturing record evaluation was performed for the finished device 31185269l, and no internal action was found during the review.Both the open circuit and the reddish material inside the pebax could be related to the electrical issue reported by the customer; therefore, the customer complaint was confirmed.The potential cause of the damage on the pebax could be related to the usage of the device during procedure; however, this cannot be conclusively determined.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.Explanation of codes: investigation findings: open circuit (c0205)/ investigation conclusions: cause not established (d15) / component code: electrical lead/wire (g02015) were selected as related to the open circuit found in the shaft area.Investigation findings: mechanical problem identified (c07) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (g04115) were selected as related to the hole in the pebax.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 UNI-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: 19047767
• MDR Text Key: 340106052
• Report Number: 2029046-2024-01135
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134721IL
• Device Lot Number: 31185269L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2024
• Date Manufacturer Received: 03/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2023
• 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