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

Model Number 2AF284

Device Problems Kinked (1339); Material Integrity Problem (2978)

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

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files for the date of the reported event and the balloon catheter, 2af284 with lot 24704, were returned and analyzed.The data files showed three ¿50005¿ system notices during the procedure indicating ¿the safety system has detected fluid in the catheter and stopped the injection¿.Visual inspection of the catheter showed the device was intact with no apparent issues.The lab test mapping catheter exhibited a difficult insertion in the balloon catheter, inside guide wire lumen closed to balloon area, therefore, the inability to insert the mapping catheter has been reproduced due to kinked guide wire lumen.The balloon catheter also failed the performance test due to system notice 50005 ¿the safety system has detected fluid in the catheter and stopped the injection¿.Dissection and pressure testing showed a guide wire lumen kinked and breach at 1.407 inches proximal from the tip.In conclusion, the reported system notice 50005 ¿the safety system has detected fluid in the catheter and stopped the injection¿ and catheter compatibility problem confirmed through testing.The balloon catheter, 2af284 with lot 24704, failed the returned product inspection due to guide wire lumen kinked and breach.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 mapping catheter was unable to be inserted in the balloon catheter.Additionally, a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection.The balloon catheter was replaced with resolve and the case was completed with cryo.No patient complications have been reported as a result of this event.(b)(6) 2018: the device was returned to the manufacturer, analyzed, and tested out of specification.No patient complications have been reported as a result of this event.

• 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: 7237566
• MDR Text Key: 98997480
• Report Number: 3002648230-2018-00060
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/02/2018

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: 08/01/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 24704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2018
• Initial Date FDA Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2017
• 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