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

Catalog Number SMART TOUCH BIDIRECTIONAL

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

Patient Problems ST Segment Elevation (2059); Stenosis (2263); No Code Available (3191)

Event Date 09/22/2020

Event Type  Injury  

Manufacturer Narrative

Patient code of ¿no code available¿ represents ¿surgical intervention." if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 male patient underwent cardiac ablation procedure for ventricular ectopy with thermocool® smart touch® sf bi-directional navigation catheter and suffered coronary artery stenosis requiring surgical intervention.During a ventricular ectopy procedure, using carto 3 system v7 with thermocool® smart touch¿ sf bi-directional navigation catheter and after extensive ablation to the right, left and coronary sinus areas, the consultant observed st-segment elevation in the patient¿s ecg.Patient wasn¿t feeling great too with his blood pressure slightly low.Lab team immediately called the interventional cardiologist on call, who after an angiogram, confirmed a complete blockage of the left main [coronary] artery.The incident was associated with the ablation.Patient is doing better today.The event was discovered post use of biosense webster products.The opinion of the physician is that the cause of the event was procedure.Percutaneous coronary intervention (pci) was performed.The patient¿s condition has improved and required extended hospitalization to monitor recovery.Dashboard, vector and visitag were used for force visualization.Visitag settings were 3mm, 3 sec , force, 25% 3g, impedance drop for color.

Manufacturer Narrative

Additional information received on (b)(6) 2020 indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.In addition, it was stated that there wasn't any product malfunction.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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; 33 technology drive; irvine CA 92618
• MDR Report Key: 10690935
• MDR Text Key: 211702754
• Report Number: 2029046-2020-01495
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; CARTO 3 SYSTEM
• Patient Outcome(s): Hospitalization; Required Intervention