MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED 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	10/17/2019
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 experienced phrenic nerve palsy (pnp).The case was completed with cryo.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 that at least seven applications were performed with balloon catheter, afapro28 with lot number 28171, without any issue on the date of the event.Another set of data files showed that at least five applications were performed with balloon catheter, afapro28 with lot number 75183, without any issue on the date of the event.In conclusion, a clinical issue was encountered during the case.The clinical could not be assessed through data analysis.There is no indication of relation of adverse event to the performance and malfunction of the product.The physical product was not returned for analysis.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARCTIC FRONT ADVANCE PRO¿ 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: 9321579
• Report Number: 3002648230-2019-00774
• Device Sequence Number: 18918312
• Product Code: OAE
• UDI-Device Identifier: 00763000088637
• UDI-Public: 00763000088637
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/12/2019

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: 06/13/2020
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 75183
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 11/14/2019
• Supplement Report FDA Received Date: 12/12/2019
• 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: Other
• Patient Age: 79 YR