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

Catalog Number D134702

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 09/19/2023

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 (stsf) for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax exposing the internal components.Initially, it was reported that after the stsf catheter was removed from the body, it was noticed that there was blood inside the tip of the catheter.The catheter was replaced, and the procedure continued.No adverse patient consequence was reported.The foreign material (blood) 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 06-feb-2024, there was a hole in the pebax exposing the internal components.The hole in the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 06-feb-2024.

Manufacturer Narrative

The device was returned to biosense webster (bwi) for evaluation.The returned device's visual inspection and microscopic analysis were performed following bwi procedures.Visual analysis revealed a damage in the pebax and traces of blood.Microscopic analysis revealed a hole in the pebax exposing the internal components.The root cause of the damage could be related to improper handling, however, this cannot be conclusively determined.The issue reported by the customer was confirmed.The broken pebax was identified during the investigation of the sample received.A manufacturing record evaluation was performed for the finished device number 31056704l, and no internal action was found during the review.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 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: 18813180
• MDR Text Key: 336677369
• Report Number: 2029046-2024-00687
• 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: 02/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134702
• Device Lot Number: 31056704L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2024
• Date Manufacturer Received: 02/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/22/2023
• 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: CARTO 3 SYSTEM; PENTARAY NAV ECO 7FR, F, 2-6-2; UNK BRAND CABLE; UNK BRAND CABLE; UNK_CARTO 3; UNK_OCTARAY NAV