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	02/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that following a cryoablation procedure, phrenic nerve palsy (pnp) was confirmed and had not resolved prior to the patient leaving the cath lab.The case was completed with cryo.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information received revealed that the patient's phrenic nerve palsy (pnp) did recover.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: clinical data files were received and reviewed.The files showed at least eight injections were performed with the returned catheter without any issues or system notices on the date of event.The catheter was returned and analyzed.Visual inspection of the device showed it was intact with no apparent issues.Smart chip verification indicated the catheter was used for eight injections.The catheter passed the performance test and electrical integrity as per specification; impedance was also within specification.Inflations were sustained for more than 2 minutes.Dissection / pressure testings did not show any leaks along the vacuum line that might have caused the deflation issue.The reported issue has not been confirmed through testing.The catheter passed the returned product inspection as per specification.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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: 6380124
• Report Number: 3002648230-2017-00107
• Device Sequence Number: 1056465
• Product Code: OAE
• UDI-Device Identifier: 00643169345614
• UDI-Public: 00643169345614
• 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,Followup
• Report Date (Section B): 04/12/2017

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: 11/22/2017
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 74531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Initial Date Received by Manufacturer: 02/10/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 04/12/2017
• Initial Report FDA Received Date: 03/06/2017
• Supplement Report FDA Received Date: 03/21/2017; 05/10/2017; 10/02/2017
• 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
• Patient Age: 41 YR