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

Catalog Number D132704

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

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 03/22/2019

Event Type  Death  

Manufacturer Narrative

The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturing record evaluation cannot be conducted because no lot number was provided by the customer.Concomitant medical products: pentaray catheter (us catalog # unknown; lot # unknown); decanav catheter (us catalog # unknown; lot # unknown); carto 3 (us catalog # unknown; serial # unknown).Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent a non-ischemic ventricular tachycardia (non-isvt) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and suffered cardiac arrest requiring cardiopulmonary resuscitation (cpr) and posteriorly died.During the last set of ablations in the left ventricle, steam pop occurred.The patient crashed and went into asystole 5/10 minutes after the last ablation and during mapping phase.Cpr was provided for over 30 minutes.The patient revived and was put in general anesthesia.A small pericardial effusion was noticed; however, no intervention was required on the effusion.Reminder of the procedure was aborted.The patient was moved to recovery and suddenly died.The cause of the death is unknown.There¿s no information regarding physician causality opinion.Patient¿s relevant history included: very sick heart transplant patient.He had 2 hearts (donor and recipient).Multiple attempts have been made to gain clarification on this event with no response.Should any new information be obtained it will be assessed and processed accordingly.

Manufacturer Narrative

On (b)(6) 2019, additional information was received about the event.It was reported that a smartablate generator (us catalog # unknown, serial # unknown) and three (3) unspecified competitor diagnostic catheters were also used during the procedure.These should be considered concomitant products.Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ 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: 8517055
• MDR Text Key: 142026791
• Report Number: 2029046-2019-02990
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009194
• UDI-Public: 10846835009194
• Combination Product (y/n): N
• PMA/PMN Number: P030031/S053
• 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: 03/25/2019

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: D132704
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/25/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 05/08/2019
• Supplement Dates FDA Received: 05/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Required Intervention