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 Device Contamination with Body Fluid (2317)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2020

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 cryo ablation procedure, it was noted there was blood in the balloon catheter.The electrical umbilical cable was replaced without resolution.The balloon catheter was replaced, which resolved the issue.The case was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the afapro28 balloon catheter with lot 56450, and the data files, were returned and analyzed.The data files showed at least eleven applications were performed with the balloon catheter on the date of the event.The data files also showed a system notice 50030 indicating the safety system has detected a high level of refrigerant flow and stopped the injection and a system notice 50001 indicating the vacuum is disabled due to a problem with the coaxial umbilical cable.Visual inspection of the balloon catheter showed the device was intact with no apparent issues.Verification of the smart chip file indicated the catheter was used for eight injections.The catheter failed the performance test due to system notice 50032 indicating that the safety system detected a compromised outer vacuum.The pressure test and dissection revealed an inner balloon pinhole.In conclusion, the reported issue of blood in the catheter could not be confirmed through data analysis and the balloon catheter failed the returned product inspection due to the inner balloon pinhole.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: 10602474
• MDR Text Key: 209446896
• Report Number: 3002648230-2020-00519
• 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: 11/06/2020

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: 06/01/2022
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 56450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2020
• Initial Date Manufacturer Received: 09/10/2020
• Initial Date FDA Received: 09/29/2020
• Supplement Dates Manufacturer Received: 10/17/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1