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	04/22/2016
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 during a cryo ablation procedure, phrenic nerve palsy (pnp) occurred which resolved prior to the patient leaving the catheterization laboratory.The procedure was completed with cryo.The pnp was determined to be a transient symptom.The patient was discharged on the normal schedule and no symptoms were present at the time of discharge.Two weeks after discharge, the patient visited the facility with a complaint of subjective symptoms of shortness of breath during exertion.X-ray photo revealed that right diaphragm was higher than normal condition and the patient was diagnosed as having phrenic nerve paralysis.The patient is currently receiving postoperative checkups and the symptoms of the pnp remain.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 twelve injections were performed with catheter 2af284/13451-09 on the date of the event.No system messages were recorded.The reported clinical issue cannot be confirmed through data analysis.Product 2af284/13451-09 has not been returned for investigation.Phrenic nerve injury encountered during the procedure.No product malfunction reported.In conclusion, this is a clinical issue encountered during the case.Product 2af284/13451-09 was not returned.Clinical issues (phrenic nerve injury) were encountered during the procedure.
Additional Manufacturer Narrative
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: 6260348
• Report Number: 3002648230-2017-00022
• Device Sequence Number: 673532
• 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,Followup
• Report Date (Section B): 01/27/2017

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: 02/08/2017
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 13451
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/20/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided; 01/27/2017; 01/27/2017
• Initial Report FDA Received Date: 01/18/2017
• Supplement Report FDA Received Date: 01/18/2017; 02/20/2017; 09/28/2017; 09/29/2017
• 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: 67 YR