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

Model Number	2AF284
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Chest Pain (1776); Dysphagia/ Odynophagia (1815); Low Blood Pressure/ Hypotension (1914); Discomfort (2330); Neck Pain (2433); No Code Available (3191)
Date of Event	01/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event summary: it was reported that one day post cryo ablation procedure, the patient experienced atypical chest pain, and was diagnosed with gastroesophageal reflux disease (gerd).Additionally, the patient had complaints of neck pain, difficulty swallowing and coughing bouts.It was also reported that the patient had hypotension.The balloon catheter was not returned for investigation.There is no indication of the reported adverse events is related to manufacturing and performance of the device.In conclusion, this is a case related to a clinical adverse event (chest pain, neck pain, cough, hypotension and difficult swallowing and digestive discomfort).The reported adverse events could not be related to the performance of the cryoablation devices.The balloon catheter was not returned for investigation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that one day post cryo ablation procedure, the patient experienced atypical chest pain, and also was diagnosed with gastroesophageal reflux disease (gerd).Additionally, the patient had complaints of neck pain, difficulty swallowing and coughing bouts.It was also reported that the patient had hypotension.The case was already completed with cryo.The patient was subsequently started on an anti-inflammatory with a proton pump inhibitor, and a modification to his current medication regimen was performed.The patient had an extended hospitalization.The patient's symptoms then resolved, and the patient was discharged from the hospital.No further patient complications have been reported as a result of this event.The patient was part of the (b)(6) clinical study.

• Brand Name: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
• Common Device Name: 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
• MDR Report Key: 7923186
• Report Number: 3002648230-2018-00701
• Device Sequence Number: 1484741
• Product Code: OAE
• UDI-Device Identifier: 00643169753693
• UDI-Public: 00643169753693
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P100010/S015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/02/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 44386
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 10/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention