MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE PRO CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	AFAPRO28
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product event summary: the balloon catheter, afapro28 with lot number 80352, was returned and analyzed.Visual inspection of the balloon catheter showed traces of blood within the inner balloon.Smart chip verification showed that the catheter had been used for 18 applications on the date of the event.The catheter passed the performance test and the electrical integrity as per specification; also, the impedance was within specification.The catheter passed the electrical continuity test.Pin-to-pin impedance measurement did not show any fluctuation.Furthermore, the catheter failed pressure test.The pressure test showed a leak through the guide wire lumen.Dissection showed a guide wire lumen breach at 1.18 inches proximal from the tip.In conclusion, the balloon catheter failed the returned product inspection due to the guide wire lumen breach.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 PRO 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: 8609555
• Report Number: 3002648230-2019-00363
• Device Sequence Number: 13953110
• Product Code: OAE
• UDI-Device Identifier: 00643169889903
• UDI-Public: 00643169889903
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2019

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: 12/20/2019
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 80352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2019
• Initial Report FDA Received Date: 05/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1