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	12/20/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cryo ablation procedure movement of the diaphragm was weakened during ablation of the right inferior pulmonary vein (ripv).The condition improved and ablation of the right superior pulmonary vein (rspv) was performed and phrenic nerve palsy (pnp) occurred.The procedure was completed with cryo but the diaphragm was only working slightly when the patient left the operating room.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Event summary: the patient data files showed at least eight injections without any issue on the date of the event ((b)(6) 2016) with catheter 2af284/ 33087-21.The cryo balloon catheter was not been returned for investigation.A phrenic nerve injury was encountered during the procedure.No product malfunction reported.In conclusion, this is a clinical issue encountered during the case.Clinical issue (phrenic nerve injury) was encountered during the procedure.The reported issue cannot be confirmed through data analysis.
Additional Manufacturer Narrative
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: 6260557
• Report Number: 3002648230-2017-00023
• Device Sequence Number: 551577
• Product Code: OAE
• UDI-Device Identifier: 00643169504783
• UDI-Public: 00643169504783
• 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,Followup
• Report Date (Section B): 02/01/2017

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: 10/04/2017
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 33087
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2016
• Supplement Date Received by Manufacturer: Not provided; 02/01/2017
• Initial Report FDA Received Date: 01/18/2017
• Supplement Report FDA Received Date: 02/27/2017; 09/28/2017
• 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