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	Cardiopulmonary Arrest (1765); Low Blood Pressure/ Hypotension (1914); Perforation of Vessels (2135)
Date of Event	07/25/2019
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 during a cryo ablation procedure, the patient's blood pressure started to decrease and the patient 'coded;' advanced cardiac life support was provided including drugs, cardiopulmonary resuscitation, and oxygen.The procedure was aborted under general anesthesia, and the patient was transferred to cardiovascular surgery.The patient had open heart surgery to repair a tear in their left superior pulmonary vein and as a result, their hospital stay was extended.It was noted that the patient had no apparent deficits in brain activity or movement and recovered fully.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: the data files were returned and analyzed.The data files showed system notice 50002 ¿the system has detected an electrical component failure¿ in multiple applications with balloon catheter 2af284 with lot number 80356.The data files showed that at least 6 applications were performed with this balloon catheter on the date of the event.Clinical issues were encountered during the case.The reported system notice is not related to the adverse event.The balloon catheter was not returned for investigation.If information is provided in the future, a supplemental report will be issued.

• 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: 8898925
• Report Number: 3002648230-2019-00597
• Device Sequence Number: 18914459
• Product Code: OAE
• UDI-Device Identifier: 00643169976382
• UDI-Public: 00643169976382
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,Followup
• Report Date (Section B): 09/09/2019

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: 04/16/2020
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 80356
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/25/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/09/2019
• 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; Life Threatening; Required Intervention