MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133601

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

Patient Problems Cardiac Arrest (1762); Death (1802); Myocardial Infarction (1969); Ventricular Fibrillation (2130); No Code Available (3191)

Event Date 03/14/2019

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.A manufacturing record evaluation was performed for the finished device 30107625m number, and no internal action was found during the review.(b)(4).

Event Description

It was reported that a (b)(6) male patient underwent a premature ventricular contraction (pvc) ablation procedure of left ventricle outflow tract (lvot) with a thermocool® smart touch¿ electrophysiology catheter and suffered myocardial infraction (requiring surgical intervention), cardiac arrest and ventricular fibrillation (requiring cardiopulmonary resuscitation (cpr and external defibrillation).During the procedure, the patient suffered myocardial infraction (mi).It happened 1 minute after the ablation started when the catheter was in the left coronary cusp.St segment elevation was observed on the ecg.The patient went into ventricular fibrillation, and cpr and external defibrillation were needed to restore the patient¿s heart rhythm.Remainder of the procedure was aborted.Surgical intervention was also required, a stent was positioned in the anterior descending coronary artery to repair the stenosis which most likely was caused by the mi.It is unknown if extended hospitalization was required.There¿s no information regarding patient¿s outcome or physician¿s causality opinion.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

Additional information was received on the event on april 5, 2019.Initially it was reported that the patient was 53 years old.The patient¿s age was 54.The patient also suffered brain death.An impella device was also placed to assist the ventricular function.The patient was transferred to the intensive care unit (icu) and required extended hospitalization.Physician¿s opinion regarding the cause of the adverse event is that it was procedure and patient condition related.Therefore, patient age at the time of event and type of reportable event were re-populated.In addition, outcomes attributed to adverse event.Is hospitalization initial/prolonged, patient codes and outcomes attributed to adverse event is death were populated.Additional information was received on the event on april 18, 2019.Cpr was performed during more than 40 minutes.Brain death was declared on (b)(6) 2019.Physician¿s opinion regarding the cause of the adverse event is that the left coronary artery was totally obstructed due to catheter movement/ablation next to the coronary ostium.Therefore, date of death was populated.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8465376
• MDR Text Key: 140338589
• Report Number: 2029046-2019-02905
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835008982
• UDI-Public: 10846835008982
• 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: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2019
• Device Catalogue Number: D133601
• Device Lot Number: 30107625M
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 53 YR