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 Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/29/2020

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, blood was found in the balloon.The balloon catheter was replaced to resolve 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 data files and afapro28 balloon catheter with lot 13087 were returned and analyzed.The data files confirmed system notice #50005 (the safety system has detected fluid in the catheter and stopped the injection) was received after 20 seconds into the inflation phase of applications eleven and twelve.The data files showed at least twelve applications were performed with the returned balloon catheter on the date of the event.The data files also showed at least two more applications were performed with non-returned balloon catheter without any issue on the date of the event.Visual inspection of the balloon catheter showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was used for twelve injections.The catheter passed the performance test and electrical integrity as per specification; impedance was also within specification.Dissection and pressure testing did not show any leaks or traces of liquid or blood inside the catheter.In conclusion, the reported visible blood issue was not confirmed through testing.The balloon catheter passed the returned product inspection as per specification.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: 10826047
• MDR Text Key: 216136422
• Report Number: 3002648230-2020-00586
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 00763000245436
• UDI-Public: 00763000245436
• 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,health
• Type of Report: Initial,Followup
• Report Date: 12/14/2020

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: 09/01/2021
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 13087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/23/2020
• Initial Date Manufacturer Received: 10/29/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/26/2020
• Supplement Dates FDA Received: 12/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1