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

Catalog Number D134721IL

Device Problems Erratic or Intermittent Display (1182); Material Puncture/Hole (1504)

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

Event Date 05/05/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and post-procedure the bwi product analysis lab identified a hole in the pebax with reddish material inside.During the procedure, the icon was waggling on the carto system screen.A second device was used to complete the operation.There was no adverse event reported on patient.The waggling icon is not mdr-reportable.The hole in the pebax is mdr-reportable.

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection and magnetic sensor functionality test of the returned device were performed following bwi procedures.Visual analysis revealed that there was a reddish material inside the pebax and a hole on the surface of the tip area.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly; no magnetic issues were observed.However, the hole at the pebax could be related to the issue reported by de customer.The root cause of the hole at the pebax cannot be determined; however, based on the information available, the condition observed most likely was originated in someplace external to the manufacturing environment.All units are inspected prior to leaving the facility as there are functional tests and inspections at control points based on the process flow diagram (pfd) per its part number to avoid this type of damage from leaving the facility.A manufacturing record evaluation was performed for the finished device 30939867l number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was confirmed.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.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® 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: 17494679
• MDR Text Key: 321083876
• Report Number: 2029046-2023-01730
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/09/2023

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: 12/05/2023
• Device Catalogue Number: D134721IL
• Device Lot Number: 30939867L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2022
• 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