MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number 2AF284

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

Patient Problems Cardiac Arrest (1762); Chest Pain (1776); Death (1802); Hematoma (1884); Hemorrhage/Bleeding (1888); Necrosis (1971); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 12/15/2016

Event Type  Death  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that post cryo ablation procedure, the patient had experienced chest discomfort and a cardiopulmonary arrest.It was noted that the patient had left the operating room conscious and in good condition.An echocardiogram was performed and a pericardial effusion was observed.Drainage and intubation were performed.The patient was placed under monitoring in the intensive care unit (icu) and died three days later.An autopsy was performed and a cause of death could not be confirmed.However, discoloration due to a hematoma was observed in the left inferior pulmonary vein (lipv) and the right inferior pulmonary vein (ripv).Also, there was blood in the patient's abdomen and necrosis due to intestinal ischemia was observed.It was "inferred" that organ dysfunction due to cardiac tamponade had occurred contributing to the cause of death.The physician reported that there was a possibility that ablated tissue had gradually bled and "it was unknown if the cause of death was due to the heart".

Manufacturer Narrative

Product analysis: data files were returned and analyzed.Data files showed temperature spikes with the catheter.Also, data files showed that at least 21 injections were performed with the catheter without issue on the date of the event.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
• Type of Device: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire, quebec H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire, quebec H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6209315
• MDR Text Key: 63403446
• Report Number: 3002648230-2016-00539
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 00643169753693
• UDI-Public: 00643169753693
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2017

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: 10/03/2017
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 21820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2016
• Initial Date FDA Received: 12/28/2016
• Supplement Dates Manufacturer Received: Not provided; 01/11/2017
• Supplement Dates FDA Received: 01/25/2017; 09/28/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/03/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 75 YR