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	Material Integrity Problem (2978); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the balloon catheter, 2af284 with lot number 04073, was returned and analyzed.Visual inspection of the balloon catheter showed the inner balloon had dried blood.Smart chip verification indicated the catheter was used for 5 injections.The catheter failed the performance test due to system notice (b)(4)¿the safety system detected fluid in the catheter and stopped the injection¿ right after connecting to the console.Dissection and pressure tests showed distortion and leak at guide wire lumen of the catheter out of balloon segment at 2.6 till 2.95 inches from the tip and also a kink was observed at balloon segment at 0.9 inches from the tip.In conclusion, the balloon catheter failed the returned product inspection due to a guide wire lumen breach and kink.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
After a completed case, the balloon catheter subsequently tested out of specification per the manufacturer's investigation.

• 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: 8616569
• Report Number: 3002648230-2019-00373
• Device Sequence Number: 16689455
• Product Code: OAE
• UDI-Device Identifier: 00643169939318
• UDI-Public: 00643169939318
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/04/2019
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 04073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2019
• Initial Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1