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

Device Problems Device Contamination with Body Fluid (2317); Material Integrity Problem (2978); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that following a successful cryo ablation procedure, blood was observed in the console.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the balloon catheter afapro28 with lot 56405, was returned and analyzed.Visual inspection showed traces of blood within the inner balloon.Smart chip verification indicates that the catheter has not been used.A system notice, 50005, indicating ¿the safety system detected fluid in the catheter and stopped the injection¿ was received.A pressure test of the catheter showed a leak though the tip.The dissection and pressure test showed inner balloon breach.Further analysis showed a guide wire lumen breach within the balloon segment and broken tc wires at the soldering point within the balloon segment.The reported issue of visual blood was confirmed the testing.The reported catheter failed the returned product inspection due to, a guide wire lumen twist and breach, as well as an inner balloon breach.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARCTIC FRONT ADVANCE PRO CARDIAC CRYOABLATION CATHETER
• Type of Device: 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: 10505755
• MDR Text Key: 206166565
• Report Number: 3002648230-2020-00467
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/19/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2022
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 56405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/08/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1