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

Model Number	AFAPRO28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	08/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product event summary: the data files were returned and analyzed.The data files show at least nine applications were performed with the afapro28 balloon catheter with lot 14592 without issue on the date of the event.In conclusion, the clinical issue (phrenic nerve palsy) occurred during the procedure.The reported issue cannot confirm through data analysis.There is no indication of a relation of the adverse event to the performance and malfunction of the product.The physical product was discarded and will not returned for analysis.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 experienced phrenic nerve palsy (pnp) while freezing the right superior pulmonary vein (rspv).The pnp did not recover during the case, and thus the case was aborted while the patient was under general anesthesia.No further patient complications have been reported as a result of this event.

• Brand Name: ARCTIC FRONT ADVANCE PRO CARDIAC CRYOABLATION CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, 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: 12456769
• Report Number: 3002648230-2021-00427
• Device Sequence Number: 17023021
• Product Code: OAE
• UDI-Device Identifier: 00763000245436
• UDI-Public: 00763000245436
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P100010/S015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/10/2021

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: 07/13/2022
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 14592
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2021
• Initial Report FDA Received Date: 09/10/2021
• 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: Other
• Patient Age: 75 YR