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

Model Number D132705

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

Patient Problems Death (1802); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969)

Event Date 11/25/2019

Event Type  Death  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.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).

Event Description

It is reported that a female underwent idiopathic ventricular tachycardia ablation procedure using the thermocool® smart touch¿ bi-directional navigation catheter and suffered hypotension, myocardial infarction and death.Post procedure the patient became hypotensive and cardiopulmonary resuscitation (cpr) was started.It was suspected that the patient was having a myocardial infarction and a coronary arteriogram, extracorporeal membrane oxygenation (ecmo), and a impella device were prepared.It is unknown at this time what the issue was.The biosense equipment worked within specifications and had no errors.It was reported that the only biosense catheter used was the mapping catheter (must be referencing the ablation catheter as this is the catheter reported during the initial call).There is no further information about the hospitalization and if any intervention was performed.The date of death was not known.The physician did not provide a causality opinion for the cause of this adverse event.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.This event will be conservatively reported under the ablation catheter ¿thermocool® smart touch¿ bi-directional navigation catheter¿.

Manufacturer Narrative

Additional clarification was received on the event on (b)(6) 2020.The procedure was performed for pvc ablation and there were no errors noted with the catheter or the carto 3 system.During the case, no concerns were reported by the physician or evidence of malfunction of the product.The case was being backed up on the carto 3 system while the patient was undergoing closure of arterial access.Suddenly, the patient became hypotensive.There was no evidence of pericardial effusion.There was possible concern for coronary involvement but this was not confirmed.Patient received resuscitative measure and was placed onto ecmo.Later, patient was taken off ecmo and subsequently expired.Therefore, per the information provided, h6.Patient codes ¿myocardial infarction/1969¿ was removed.Manufacturer¿s reference number: (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: 9498370
• MDR Text Key: 172185393
• Report Number: 2029046-2019-04033
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• 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
• Type of Report: Initial,Followup
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM.; UNK_SMARTABLATE GENERATOR.; UNK_SMARTABLATE PUMP.
• Patient Outcome(s): Death