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 Bacterial Infection (1735); Stroke/CVA (1770); Chest Pain (1776); Death (1802); Low Blood Pressure/ Hypotension (1914); Inflammation (1932); Perforation of Esophagus (2399)

Event Date 02/06/2017

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 the patient is deceased.It was additionally reported that two weeks post cryo ablation procedure, the patient developed chest pain and had symptoms of a bacterial infection.The patient was re-admitted, and it was observed the patient developed partial esophageal perforation and underwent repair surgery.The patient was re-admitted again and underwent an open esophageal repair.Later, it was determined that the repair was ¿leaking¿, and the patient was brought back and an esophageal stent was deployed.Then a bronchial stent was deployed after an undetermined period after the esophageal stent was deployed.Shortly after stent repair surgeries, the patient suffered a cerebral infarction which led to their death.The physician added that it was likely secondary to the esophageal perforation.Additional information indicated that after the cryo ablation therapy, the patient received radiofrequency (rf) therapy from a competitor product.

Manufacturer Narrative

Event summary: one data file is attached to complaint records.The data file is a power up test file.No patient file is attached yet to the complaint records.Power up test file showed the console was powered on the date of event and passed the power up test.The catheter 2af284/97805 was not returned for investigation.Two weeks post cryo ablation procedure, the patient developed chest pain and had symptoms of a bacterial infection.The patient was re-admitted, and it was observed the patient developed partial esophageal perforation and underwent repair surgery.The patient deceased post cryoablation procedure.In conclusion, this is a case related to a clinical issue (partial esophageal perforation and death).The catheter used in the case was not returned.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.

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.

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.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It further reported that the patient experienced mediastinitis and died of related complications.

• 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,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6432843
• MDR Text Key: 70856395
• Report Number: 3002648230-2017-00128
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 00643169753693
• UDI-Public: 00643169753693
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/09/2017
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 97805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/09/2016
• 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: 70 YR