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

Catalog Number D134804

Device Problems Erratic or Intermittent Display (1182); Material Puncture/Hole (1504); Contamination /Decontamination Problem (2895)

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

Event Date 04/28/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) paroxysmal ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and post-procedure the bwi product analysis lab found a hole on the pebax with internal parts exposed.During the procedure, the catheter icon was jumping on the carto 3 system during radiofrequency (rf).The cable and indifferent electrodes were replaced without resolution.The medical team stated that the catheter appeared to have blood infiltrated in the tip.The icon jumping is not mdr-reportable.The blood on the tip is not mdr-reportable.The hole on the pebax with internal parts exposed is mdr-reportable.

Manufacturer Narrative

The product investigation was completed.Device evaluation details: the device was returned to biosense webster for evaluation.A visual inspection and magnetic sensor functionality test of the returned device were following biosense webster (bwi) procedures.Visual analysis of the returned device revealed reddish brown material inside and a hole on the pebax with internal parts exposed.A magnetic sensor functionality test was performed, and the device was recognized on the system; however, error 105 was displayed on the screen due to an open circuit in the tip area.The foreign material described by the costumer was confirmed; however, the blood inside the pebax area found could be related to the icon jumping.The instructions for use contain the following recommendations: improperly positioned patches may increase the chances of a virtual magnetic reference move unrelated to patient movement.This could also result in inaccurate catheter visualization.A manufacturing record evaluation was performed for the finished device 30960954l number, and no internal actions related to the complaint were found during the review.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.

• 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: 17495519
• MDR Text Key: 321145216
• Report Number: 2029046-2023-01743
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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
• 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

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D134804
• Device Lot Number: 30960954L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2023
• Date Manufacturer Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2022
• 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; SWARTZ SL1 8.5FR