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

Catalog Number D134805

Device Problem Failure to Sense (1559)

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

Event Date 01/24/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial flutter (afl) procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole in the pebax exposing internal components.Error 401 (map points cannot be acquired), error 105 (magnetic sensor error), and other unknown errors were intermittently displayed on the carto 3 system.They moved the metal away from the bed and moved the ii without resolution.The cable was replaced with no resolution.When the catheter was replaced, the issue was resolved.No patient consequence reported.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 28-feb-2024, observed damage in the pebax and traces of blood.Microscopic analysis revealed a hole in the pebax exposing internal components.This event was originally considered non-reportable, however, bwi became aware of a hole in the pebax exposing internal components on (b)(6)2024 and have assessed this returned condition as reportable.The awareness date for this returned condition is (b)(6)2024.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 21-feb-2024.The device evaluation was completed on 28-feb-2024.The device was returned to biosense webster (bwi) for evaluation.The returned device's visual inspection, magnetic sensor functionality test 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 device was connected to the carto 3 system and it was recognized and visualized correctly.No issues or errors were observed.Nevertheless, the device's condition upon return could be a contributing factor to the reported event.The issue reported by the customer was confirmed.Product failure is multifactorial.A manufacturing record evaluation was performed for the finished device, 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.Manufacturer¿s reference number: pc-(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: 18946381
• MDR Text Key: 338552031
• Report Number: 2029046-2024-00961
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134805
• Device Lot Number: 31191124L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2023
• 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
• Treatment: UNK CABLE; UNK_CARTO 3