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 Kinked (1339)

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

Event Date 11/18/2017

Event Type  malfunction  

Manufacturer Narrative

Event summary: the first set of patient files showed at least three injections were performed with catheter 2af283/ 96339-46 on the date of the event, system notice (#(b)(4)) was received indicating that the safety system detected a high level of refrigerant flow and stopped the injection was triggered on all three applications.The second set of patient data files showed at least one injection was performed with catheter 2af283/ 96339-46 on the date of the event, a system notice (#(b)(4)) was received indicating that the safety system detected a high level of refrigerant flow and stopped the injection was triggered.Upon visual inspection of catheter 2af283 / 96339-46, results showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was used for four injections.The catheter failed the performance test due to system notice (#(b)(4)) received indicating that the safety system detected a compromised outer vacuum.Dissection and pressure tests showed a leak at 0.5 psi check valve in the y-block.The balloon catheter failed the returned product inspection due to leak through the 0.5 check valve (in the y-block) and guide wire lumen kink.In conclusion, the balloon catheter failed the returned product inspection due to a leak through the check valve (in the y-block) and guide wire lumen kink.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, a system notice was received indicating that the safety system detected a high level of refrigerant flow and stopped the injection.The procedure was aborted.No patient complications have been reported as a result of this event.On 2017-12-15, 09:44:44: incoming information indicated that the console was serviced as appropriate.On 2018-02-22: the sheath and balloon catheter subsequently tested out of specification per the manufacturer's investigation.

• 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
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7295955
• MDR Text Key: 100936892
• Report Number: 3002648230-2018-00109
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2018

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: 07/20/2019
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 96339
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1