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	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Nerve Damage (1979)
Date of Event	11/28/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a cryoablation procedure, the patient had phrenic nerve injury on the first freeze of the right superior pulmonary vein.The case was aborted and the patient was under general anesthesia.The patient was placed on a ventilator due to lost phrenic nerve capture in the right superior pulmonary vein (rspv).After the procedure the patient was upgraded to a biventricular icd, after which there was phrenic nerve capture.No further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary: device and data files were returned and analyzed.The data files did not show any system notices or issues for the returned catheter.Visual inspection of the catheter showed that the device was intact with no apparent issues.Smart chip verification indicated that the catheter been used for 12 injections.This is a clinical issue encountered during the procedure.In conclusion, the reported issue was not confirmed through testing.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; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• MDR Report Key: 6186240
• Report Number: 3002648230-2016-00531
• Device Sequence Number: 16400816
• Product Code: OAE
• UDI-Device Identifier: 00643169345614
• UDI-Public: 00643169345614
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P100010
• 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,Followup
• Report Date (Section B): 11/28/2016

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: 08/17/2017
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 61571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2017
• Initial Date Received by Manufacturer: 11/28/2016
• Supplement Date Received by Manufacturer: Not provided; 01/18/2017
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 02/06/2017; 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; Required Intervention
• Patient Age: 76 YR