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	Nerve Damage (1979)
Date of Event	04/26/2019
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, phrenic nerve palsy (pnp) occurred.The ablation was stopped and the pnp was monitored.The pnp had not recovered at the end of the case.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 nine applications were performed with balloon catheter 2af284 with lot number 35109.A clinical issue, phrenic nerve palsy (pnp) was encountered during the procedure.In conclusion, the balloon catheter was not returned for investigation.There is no indication of relation of adverse event to the performance of the cryo device.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: 8600892
• Report Number: 3002648230-2019-00347
• Device Sequence Number: 2180802
• Product Code: OAE
• UDI-Device Identifier: 00643169939318
• UDI-Public: 00643169939318
• 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,Followup
• Report Date (Section B): 06/06/2019

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: 01/22/2020
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 35109
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/26/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 05/10/2019
• Supplement Report FDA Received Date: 06/06/2019
• 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