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

Catalog Number D133605IL

Device Problems Break (1069); Temperature Problem (3022)

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

Event Date 02/27/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) with a thermocool® smart touch¿ electrophysiology catheter for which biosense webster¿s product analysis lab revealed a separation on the tip-shaft transition.The temperature and impedance test was performed, and no temperature was displayed due to an open circuit on the tip area.It was reported that during procedure, there is no temperature displayed on the carto or generator.A second device was used to complete the operation.There was no adverse event reported on patient.No temperature is not mdr-reportable.Broken tip is mdr-reportable.

Manufacturer Narrative

The product investigation was completed.Device evaluation details: a picture was received for evaluation following biosense webster's procedures.According to the pictures provided by the customer, no temperature was observed on the generator screen.Visual analysis revealed a separation on the tip-shaft transition.The temperature and impedance test was performed, and no temperature was displayed due to an open circuit on the tip area.Pu (polyurethane) was found applied correctly on tip-shaft transition, proving that the device was manufactured properly.This condition may have been originated during the manipulation of the device during shipping, however, this cannot be conclusively determined.A manufacturing record evaluation was performed for finished device number 30845247m, and no internal actions related to the complaint 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 the following warning stated in the carto 3 system manual: if the radiofrequency (rf) generator does not display temperature, verify that the appropriate cable is plugged into the rf generator.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¿ 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: 16841517
• MDR Text Key: 314527517
• Report Number: 2029046-2023-00927
• 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: 04/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2023
• Device Catalogue Number: D133605IL
• Device Lot Number: 30845247M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2023
• Date Manufacturer Received: 04/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2022
• 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; UNSPECIFIED GENERATOR