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

Model Number 2AF283

Device Problem Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/04/2020

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,the sheath was aspirated and air bubbles were aspirated into the syringe.The sheath and balloon catheter were replaced.Prior to the procedure, the system was correctly aspirated and flushed.When aspirating initially after catheter insertion, no air bubbles were observed.The case was completed with cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the balloon catheter, 2af283 with lot number 36480, was returned and analyzed.Visual inspection of the balloon catheter showed it was intact with no apparent issues.Smart chip verification indicated the catheter was never used for injections.The catheter passed the performance test; electrical integrity and impedance were also within specification.Dissection / pressure testing did not show any leaks or traces of liquid/blood inside the catheter.There was no air ingress issue was discovered during the compatibility test with a test sheath.In conclusion, the reported issue was not confirmed on the balloon catheter.The balloon catheter passed the returned product inspection per specification.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARCTIC FRONT ADVANCE® 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: 9772175
• MDR Text Key: 195443889
• Report Number: 3002648230-2020-00128
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• PMA/PMN Number: P100010
• 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: 04/10/2020

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: 12/12/2021
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 36580
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/28/2020
• Supplement Dates Manufacturer Received: 03/25/2020
• Supplement Dates FDA Received: 04/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4FC12 SHEATH