MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_SMART TOUCH BIDIRECTIONAL SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 08/16/2023

Event Type  Death  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with an unknown smarttouch bidirectional sf catheter.The patient suffered cardiac tamponade requiring a pericardiocentesis and ultimately passed away.The patient's pericardial tamponade and subsequent passing occurred on (b)(6) 2023.The issue occurred at the stage of the partial isolation of the left veins then steam pop in the area of the anterior roof.The length of the ablation cycle when the pop was observed at the same tip position was about 10 seconds.After the mid-procedure steam pop, the medical team stopped and checked the catheter but didn't see any issue.The steam pop occurred at radiofrequency (rf) ablation in the area of the left atrial (la) roof (at an ablation index of 400, st sf catheter, 50watts) in the middle of a pericardial tamponade.The procedure continued.The physician's opinion on the cause of the event was a combination of steam pop and oral anticoagulation with clopidogrel and noak (non-vitamin k antagonist oral anticoagulants).After the percardial tamponade, the patient was transferred to the intensive care unit (icu).The intervention plan was to transfer the patient to the patient to another hospital.The patient had received cpr as well.However, the patient died in the icu.Transseptal puncture was performed with a brk 1 abbott.An irrigated catheter was used in the event with a flow setting of 2ml low flow and 8 high flow, above 30 watts and 15 flow.The correct catheter settings were selected on the generator.The pump switching functioned properly and could be maneuvered from ¿low¿ to ¿high¿ flow during ablation.All force visualization features were used.Visitag module was used, parameters for stability used was max distance change 3 mm; minimum time 3 sec; fot (force over time) 25%; minimum force 3g; tag size 3.Fti (force time interval) was used as well.The steam pop is not mdr-reportable.All deaths where bwi fda approved ¿ ce mark devices are involved are reportable.

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the no lot number was provided by the customer.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.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: UNK_SMART TOUCH BIDIRECTIONAL SF
• 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: 17809096
• MDR Text Key: 324157483
• Report Number: 2029046-2023-02154
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 09/24/2023

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 Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: No
• 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: BRK 1 ABBOTT NEEDLE; CARTO 3 SYSTEM; CARTO VISITAG MODULE; SMARTABLATE GENERATOR KIT-WW; UNSPECIFIED PUMP
• Patient Outcome(s): Life Threatening; Death; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Male
• Patient Weight: 105 KG