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

Model Number D134702

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

Patient Problems Cardiac Tamponade (2226); Heart Failure/Congestive Heart Failure (4446)

Event Date 11/09/2020

Event Type  Death  

Manufacturer Narrative

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 ref.# (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure for left atrial tachycardia with thermocool® smart touch® sf uni-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and death.It was reported that during use of biosense webster product, during ablation phase, the patient suffered cardiac tamponade treated with pericardiocentesis and expired in the operating room.The physician considers procedure as the cause of the event and heart failure due to cardiac tamponade as he cause of death.Graph, vector and visitag were used for force visualization.The visitag settings were range: 3mm for time 3sec; force over time (fot) 25% of 3g.Ablation index was used as prospective color option.Transseptal was performed with brk needle (abbott).Ablation was performed before effusion however no steam pop was observed.Standard irrigation settings were used (8ml/min up to 30w and 15ml/min above 30 w).

Manufacturer Narrative

On (b)(6) 2020, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent cardiac ablation procedure for left atrial tachycardia with thermocool® smart touch® sf uni-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and death.It was reported that during use of biosense webster product, during ablation phase, the patient suffered cardiac tamponade treated with pericardiocentesis and expired in the operating room.Device evaluation details: the device evaluation has been completed.The device was visually inspected and it was found in good conditions.The magnetic, temperature and force features were tested and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Since the device was manufactured in accordance with documented specifications and procedures.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref#: (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4), on (b)(6) 2021, it was noticed the h6.Health effect - clinical code "e0611" (heart failure/congestive heart failure) was incorrectly reported on the 3500a initial medwatch report.Please consider this code as removed.

• Brand Name: THERMOCOOL SMART TOUCH SF UNI-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: 10958675
• MDR Text Key: 219883355
• Report Number: 2029046-2020-01882
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/09/2020

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 Expiration Date: 09/21/2021
• Device Model Number: D134702
• Device Catalogue Number: D134702
• Device Lot Number: 30438206L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Manufacturer Received: 11/09/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 12/23/2020; 01/07/2021; 02/15/2021
• Supplement Dates FDA Received: 01/07/2021; 01/31/2021; 02/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BRK NEEDLE BY ABBOTT.; CARTO 3 SYSTEM.; SMARTABLATE GENERATOR SPARE-WW.; BRK NEEDLE BY ABBOTT; CARTO 3 SYSTEM; SMARTABLATE GENERATOR SPARE-WW
• Patient Outcome(s): Death; Required Intervention