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

Model Number D134805

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Vasoconstriction (2126); Ischemic Heart Disease (2493); Pericardial Effusion (3271)

Event Date 04/03/2023

Event Type  Death  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf).The patient experienced arterial spasm, pericardial effusion, and electrocardiogram st segment elevation, requiring surgical intervention and prolonged hospitalization.The patient eventually passed away.It was reported that blood pressure decreased after pulmonary vein isolation (pvi) was completed.After completion of pvi, blood pressure fell, and percutaneous cardiopulmonary support systems (pcps) was inserted, and the procedure was terminated.An st elevation and hypotension occurred.Progress was reported as a serious adverse event.Prolonged hospitalization was needed.Method of contact force (cf) monitoring was with dashboard, vector, visitag.Visitag coloring settings was tag index.A smartablate generator, product code: m4900207, serial number: g4c¿1258 was used.Stsf was used for pvi.Visitag module was used, parameters for stability used was range: 3mm, time: 3s, fot: 25%, tag size: 3mm.Additional filter used with the visitag was fot.Coronary angiography showed spasm, and pericardial fluid was present originally but not increased.The cause was unknown, but it was possible that the coronary artery was clogged with a thrombus.Relevant medical history: heart failure, moderate mitral regurgitation.After the end of the procedure, the patient was hospitalized under pcps for an extended hospitalization period for follow-up observation, and recovery of blood pressure was once confirmed.On (b)(6) 2023, the patient was weaned from pcps intubation in the morning, but was intubated again and died in the evening.Detailed information on the direct cause of death and circumstances leading to death was not available.The physician¿s opinion on the cause of this adverse event was that it was patient condition related.The physician commented that the cause was unknown but there was a possibility that a thrombus was clogged in the coronary artery.

Manufacturer Narrative

E 1.Initial reporter phone: (b)(6).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

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30985809l number, and no internal action related to the complaint was found during the review.Additionally, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.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: 16853618
• MDR Text Key: 314379881
• Report Number: 2029046-2023-00937
• 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,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

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: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30985809L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/04/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 06/17/2023
• Supplement Dates FDA Received: 07/14/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/08/2023
• 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: OCTA,STD,48P,2-2-2-2-2,D-CURVE; SMARTABLATE GEN. KIT (JAPAN); SOUNDSTAR ECO GE 8F CATHETER; SOUNDSTAR ECO GE 8F CATHETER; UNK_CARTO 3
• Patient Outcome(s): Life Threatening; Hospitalization; Death; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male
• Patient Weight: 85 KG