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 Codes	Adverse Event Without Identified Device or Use Problem (2993); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/05/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during to a cryo ablation procedure, a kink was observed in the tubing under the balloon followed by a system notice was received indicating that the safety system detected a compromised outer vacuum.The case was aborted and the patient was under general anesthesia.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Product event summary data files were received and analyzed and confirm system notice 50032 ¿the safety system has detected a compromised outer vacuum¿ on 05 january 2017, the date of the event.The files showed at least two injections were performed with this catheter.The product was received and analyzed.Visual inspection of the catheter showed that the catheter was intact with no apparent issues.Smart chip verification showed that the catheter has been used for 2 injections on date of event.The catheter passed the performance test as per specification.The catheter passed the electrical continuity test.Pin-to-pin impedance measurement did not show any fluctuation.The dissection/pressure test did not show any obstruction or leak that might have caused the system notice 50032 (outer vacuum compromised).Dissection also showed a guide wire lumen kink inside the balloons at 1.32 inches from the tip.Pressure test of the guide wire lumen did not show leaks.The reported system notice (b)(4) issue was not reproduced through testing but confirmed through data analysis.The catheter failed the inspection due to a guide wire lumen kink.
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: 6283009
• Report Number: 3002648230-2017-00055
• Device Sequence Number: 13591493
• Product Code: OAE
• UDI-Device Identifier: 00643169504783
• UDI-Public: 00643169504783
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P100010/S015
• 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,Followup
• Report Date (Section B): 01/05/2017

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: 11/03/2017
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 50164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Initial Date Received by Manufacturer: 01/05/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 03/15/2017
• Initial Report FDA Received Date: 01/27/2017
• Supplement Report FDA Received Date: 03/03/2017; 03/15/2017; 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