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 Problem Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a cryoablation procedure, air was present while aspirating after inserting the balloon catheter into the sheath.The sheath was replaced but air was still present.The balloon catheter was replaced.The case was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the balloon catheter afapro28 with lot number 57851 was returned and analyzed.Visual inspection of the balloon catheter showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was used for one injection.The outer diameter of the balloon proximal bonding was within specification.Insertion and retraction tests were performed with difficulty.The push button of the catheter was in the back position.The length of balloon segment was 0.88¿.The balloon was wrapped on itself and it was difficult to put back the balloon sleeve on it.Advancing the push button on the catheter handle during balloon deflation stretched the balloon to maximum length allowing the folds in the balloon material to wrap tightly, reducing the profile of the balloon segment for ease of re-entry into the sheath.Push button retracting during insertion was identified as a cause of the insertion difficulty, as it causes the balloon material to fold up in itself increasing the outer diameter.Retraction is not controlled and varies from one catheter to another.After inflating the balloon and deflating while pushing the push button in the forward position, balloon wrapped properly and the length of balloon segment was 1.15¿ then inserted easily into test sheath.The balloon catheter passed the electrical, integrity test and performance test.The shape of the balloon was normal.The flushing and aspiration test was also performed several times inside the sheath without any issue.In conclusion, the reported air ingress was not confirmed through testing.The balloon catheter passed the returned product inspection.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: 10507899
• MDR Text Key: 206147114
• Report Number: 3002648230-2020-00470
• 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: 11/01/2020

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: 11/07/2021
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 57851
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 08/20/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 10/08/2020
• Supplement Dates FDA Received: 11/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1