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

Model Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Ischemic Heart Disease (2493)

Event Date 11/17/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 30892136l and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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 patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered an electrogram st segment elevation which required coronary angiography inspection.St increased during conducting cti ablation.Ablation was interrupted.The symptoms returned to normal spontaneously after approximately 10 minutes.When coronary angiography inspection was performed, no abnormal sites were identified.There was no problem with the patient and the patient left the room.The physician's opinions on the relationship between the event and the product was that because of the anatomical proximity to the rca, transient stenosis is suspected.There is no relationship with the product.There were no abnormalities observed prior to and during use of the product.No relevant medical history.No relevant tests/laboratory data.Additional information was received.The adverse event was discovered during ablation.Physician¿s opinion on the cause of this adverse event was that there is no relationship with the ablation system.The event resolved shortly after coronary angiography inspection was performed.The patient's course was normal.Extended hospitalization was not required.The monitoring at the hospital ward on the day of procedure was also as usual.

Manufacturer Narrative

Additional information received was received on 26-jan-2023.Coronary angiography was performed.Other intervention was not conducted.Outcome of the adverse event was improved.Patient did not require extended hospitalization because of the adverse event.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 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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15992757
• MDR Text Key: 305584469
• Report Number: 2029046-2022-03141
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30892136L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/17/2022
• Initial Date FDA Received: 12/15/2022
• Supplement Dates Manufacturer Received: 01/26/2023
• Supplement Dates FDA Received: 02/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/02/2022
• 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: SMARTABLATE GEN. KIT (JAPAN)
• Patient Outcome(s): Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 53 KG