MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133604IL

Device Problem Failure to Sense (1559)

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

Event Date 02/26/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and post procedure the bwi product analysis lab identified a hole in the pebax with internal components exposed.During the procedure, the medical team identified an 106 alert code after the catheter was plugged into the carto and before the first ablation.A second device was used to complete the operation.There was no adverse event reported on patient.Catheter was not used in patient.

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the 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 revealed reddish material in the pebax.Microscopic analysis revealed a hole in the pebax exposing the internal components.A screening test was performed and the device was recognized and visualized correctly; however negative force vector appeared in the system with high force readings due to insufficient adhesive application on the wires inside the tip.This adhesive issue is attributed to the manufacturing process.A manufacturing record evaluation was performed for the finished device number 31059817m, and no internal action was found during the review.The force and temperature issues reported by the customer were confirmed based on the observed adhesive condition.Additionally a hole in the pebax was detected during the product investigation.The root cause of the hole in the pebax could be related to the improper handling, however, this cannot be conclusively determined.The instructions for use contain the following warning stated in the carto 3 system manual: if force readings might be inaccurate or another catheter is in proximity: an alert message appears, force readings on the dashboard are displayed in gray, and the force graph is colored white.Resolve the issue according to the directions in the alert message to enable force measurement.You can also continue the study without force data.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY 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: 19109880
• MDR Text Key: 340908301
• Report Number: 2029046-2024-01238
• 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: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2024
• Device Catalogue Number: D133604IL
• Device Lot Number: 31059817M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2024
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2023
• 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