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 Problems Stenosis (2263); Ischemic Heart Disease (2493)

Event Date 05/02/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a premature ventricular contraction ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered coronary artery stenosis and electrocardiogram st segment elevation.It was reported that st elevation occurred right after ablation of lcc.Timing was right after lcc ablation.The patient was treated with cag coronary balloon, and blood flow and blood pressure were stabilized.Therefore, the patient was followed up in intensive care unit (icu).Description of health problems (other) was coronary artery stenosis.Progress (current patient's condition condition) was a balloon was used to secure blood flow and the patient was returned to the icu after confirming that the st elevation had subsided.Prolonged hospitalization was required.Method of cf monitoring used was real time graph, dashboard and visitag.Visitag coloring settings was tag index.The physician's opinions on the relationship between the event and the product was to be added after confirmation from the physician.

Manufacturer Narrative

1.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 30974515l and no internal actions 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).

Manufacturer Narrative

Additional information was received.Physician¿s opinion on the cause of this adverse event was the procedure.Lmt might have been occluded during lcc ablation, which was near the coronary artery.The patient remained unconscious.The physician believes the brain might have been transient hypoxic due to coronary artery vasospasm.Generator information was a smartablate generator, model: m4900207, serial number: (b)(4).At the time st elevation was observed, smarttouch sf was placed at the leaflet in left ventricle.The competitor¿s rv catheter was placed in right ventricle.Pentaray catheter and soundstar catheter were not inserted intracardiac.Therefore, processed the d 10.Concomitant medical products and therapy dates field.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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17017352
• MDR Text Key: 316117962
• Report Number: 2029046-2023-01169
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

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: 30974515L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2023
• Initial Date FDA Received: 05/29/2023
• Supplement Dates Manufacturer Received: 06/05/2023
• Supplement Dates FDA Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2023
• 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: NON BWI-RV CATHETER; PENTARAY NAV ECO 7FR, D, 2-6-2; SMARTABLATE GEN. KIT (JAPAN); SOUNDSTAR ECO GE 8F CATHETER; UNK_CARTO 3
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 19 YR
• Patient Sex: Female
• Patient Weight: 48 KG