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 Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	02/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that following a cryoablation procedure that was completed with cryo, the patient was noted to be hypotensive overnight.The patient was transferred to the intensive care unit (icu) for monitoring, where he received vasopressor support.Phenylephrine was given intravenously, and oral sotalol and losartan were discontinued.A limited echocardiogram was performed and effusion was ruled out.Hemoglobin was checked periodically and found to be stable.The patient was discharged.The episode of hypotension was determined to be secondary to anesthesia.No further patient complications have been reported as a result of this event.The patient was enrolled in the (b)(6) 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: 8499406
• Report Number: 3002648230-2019-00261
• Device Sequence Number: 16615533
• Product Code: OAE
• UDI-Device Identifier: 00643169939318
• UDI-Public: 00643169939318
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 04/10/2019

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: 12/12/2019
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 80575
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/15/2019
• Initial Report FDA Received Date: 04/10/2019
• 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
• Patient Age: 72 YR
• Patient Weight: 102