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

Catalog Number D134805

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 10/26/2023

Event Type  malfunction  

Manufacturer Narrative

The device evaluation was completed on 10-jan-2024.The smart touch bidirectional sf device was returned to biosense webster (bwi) for evaluation.A visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis of the returned sample revealed reddish material in the pebax.The device was connected to the carto 3 system and it was recognized; however, error 105 was displayed on the screen due to an open circuit in the tip area.Scanning electrode microscope analysis was performed and it shows evidence of mechanical damage and a hole on the pebax surface.The blood found inside the pebax area may contribute to the visualization issue.A manufacturing record evaluation was performed and no internal action was found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The instructions for use contain (ifu) the following recommendations: the magnetic sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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: 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 customer¿s reported ¿icon was "shaking on the carto 3 system" and biosense webster inc.Analysis finding of the ¿reddish material in the pebax and a hole on the pebax surface¿.-investigation findings: open circuit (c0205) investigation conclusions: cause not established (d15) / component code: sensor (g03012) were selected as related to the customer¿s reported ¿icon was "shaking on the carto 3 system" and biosense webster inc.Analysis finding of the ¿open circuit in the tip area¿.Manufacturer¿s reference number: (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified a hole on the surface of the pebax.Initially, the thermocool® smart touch® sf bi-directional navigation catheter icon was "shaking" during radio frequency (rf) delivery on the carto 3 system.There were no errors present.To troubleshoot, the patient table and ii were raised without resolution.The cable was exchanged without resolution.The catheter was exchanged and the issue resolved.The procedure was continued successfully.There was no patient consequence reported.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 10-jan-2024, there was reddish material in the pebax observed.A scanning electrode microscope analysis was performed and it showed evidence of mechanical damage and a hole on the pebax surface.This event was originally considered non-reportable, however, bwi became aware of a hole on the surface of the pebax on 10-jan-2024 and have assessed this returned condition as reportable.

• 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: 18616009
• MDR Text Key: 335087581
• Report Number: 2029046-2024-00358
• 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: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2024
• 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: 31089623L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2023
• Date Manufacturer Received: 01/10/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2023
• 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