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	Pulmonary Valve Stenosis (2024)
Date of Event	12/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the data files were returned and analyzed.The data files showed at least 7 applications were performed with balloon catheter, 2af284 with lot number 74986, without any issue on the date of the event.The balloon catheter was not returned for investigation.Clinical issues occurred post-procedure.There is no indication of relation of the adverse event to the performance/ malfunction of the product.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that nine months post cryo ablation procedure, the patient had severe stenosis in the left superior pulmonary vein (lspv) and right superior pulmonary vein (rspv) as noted via computed tomography (ct) scan.The patient is asymptomatic, and there was no medical intervention and extended hospitalization noted.No further patient complications have been reported as a result of this event.Additional information indicated that the pv stenosis had worsened, requiring a percutaneous transluminal angioplasty (pta) to be scheduled.Furthermore, it was reported that the stenosis occurred due to neointimal proliferation and there was some injury brought to the vessel wall.

• 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: 8418367
• Report Number: 3002648230-2019-00188
• Device Sequence Number: 11155840
• Product Code: OAE
• UDI-Device Identifier: 00643169753693
• UDI-Public: 00643169753693
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P100010/S015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/13/2019

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: 06/27/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 74986
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2019
• Initial Report FDA Received Date: 03/13/2019
• 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: Required Intervention