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

Model Number D134805

Device Problems Device Contamination with Body Fluid (2317); High Readings (2459); Contamination /Decontamination Problem (2895)

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

Event Date 05/06/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster inc, (bwi).Product analysis lab observed a hole in the pebax.Initially, it was reported that after right pulmonary vein isolation (rpvi) was ended, during left pulmonary vein isolation (lpvi), the impedance value gradually increased and was observed several times.When it was taken out of the patient¿s body and visually checked, it was confirmed that a char was attached at the tip.Irrigation defect occurred after ablation.Total ablation time in this procedure is about 20 minutes.Mean contact force (cf) value did not exceed 25g.Mean cf value did not exceed 40g.Irrigation setting was within the specified range.Pre-radiofrequency (rf) time and post rf time were, pre was 1 second, post was 3 seconds.The site where the thrombus was attached was around the area between the 2nd and 3rd poles of the electrode.Set output was 40w.The catheter was replaced, and the procedure was completed without patient consequence.The char issue was assessed as not mdr reportable.Char is a physical phenomenon of rf energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.In addition, biosense webster inc.Has reassessed the reportability of char-related events and has determined that these events, which were previously reported as malfunctions, are ¿not reportable.¿ the fda has provided documented concurrence with this.The high impedance was assessed as not mdr reportable.No rf could be delivered with the high impedance.The potential risk is low.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found a hole in the pebax with reddish material.However, no char evidence was observed on the device.The awareness date for this reportable lab finding is 27-jul-2022.

Manufacturer Narrative

Initial reporter phone: (b)(6).The biosense webster, inc.Product analysis lab received the device on 07-jun-2022.The device evaluation was completed on 27-jul-2022.Visual inspection, temperature, impedance, and irrigation tests of the returned device were performed following bwi procedures.Visual analysis revealed a hole in the pebax with reddish material.However, no char evidence was observed on the device.An irrigation test was performed, and the device was found working correctly.Also, temperature and impedance tests were performed, and no anomalies were observed.A manufacturing record evaluation was performed for the finished device number 30726705l, and no internal actions related to the reported complaint condition were identified.The char issue reported by the customer could not be confirmed.Char is an expected phenomenon of radiofrequency (rf) ablation.To minimize the temperature issues, the following guidelines should be followed: monitor the catheter tip temperature throughout the procedure to ensure adequate irrigation.If temperature increases to 40°c during rf energy delivery, power delivery should be interrupted.The damage in the pebax observed can be related to the impedance issue experienced by the customer, which can be confirmed.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.(b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15279328
• MDR Text Key: 305550929
• Report Number: 2029046-2022-01961
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30726705L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2022
• Date Manufacturer Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/05/2022
• 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: UNK BRAND CATHETER