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

Model Number D133601

Device Problem Signal Artifact/Noise (1036)

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

Event Date 05/17/2022

Event Type  malfunction  

Manufacturer Narrative

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).

Event Description

It was reported that a 61 year old, female patient underwent an atrial flutter (afl) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and an issue with bad/no ecg signal on all channels occurred.It was reported that there was no ecg signals while the catheter was inside the patient¿s body.There was signal interference (noise) observed on all ecg (bs + ic) channels.It was observed on both the carto® and recording system.No ecg was available to monitor patient heart rhythm.The procedure was delayed 5 minutes.The catheter was replaced, and the procedure was successfully completed with no patient consequences.The issue with bad/no ecg signal on all channels was assessed as a mdr reportable product malfunction.

Manufacturer Narrative

The biosense webster inc.(bwi) product analysis lab received the device for evaluation on 20-jun-2022.The device evaluation was completed on 27-jun-2022.It was reported that a 61-year-old, female patient, underwent an atrial flutter (afl) ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and an issue with bad/no ecg signal on all channels occurred.It was reported that there was no ecg signals while the catheter was inside the patient¿s body.There was signal interference (noise) observed on all ecg (bs + ic) channels.It was observed on both the carto® and recording system.No ecg was available to monitor patient heart rhythm.The procedure was delayed 5 minutes.The catheter was replaced, and the procedure was successfully completed with no patient consequences.Device evaluation details: the device was returned to biosense webster inc.(bwi) for evaluation.Visual inspection and electrical tests of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.An electrical test was performed, and no electrical issues were found.The electrical issue reported by the customer could not be replicated during the product investigation.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendation: ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.A manufacturing record evaluation was performed for the finished device 30723891m number, and no internal actions related to the complaint were found during the review.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14691629
• MDR Text Key: 294286821
• Report Number: 2029046-2022-01304
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: D133601
• Device Catalogue Number: D133601
• Device Lot Number: 30723891M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2022
• 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
• Patient Age: 61 YR
• Patient Sex: Female