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

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

Event Date 01/22/2018

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files for the date of the reported event and the balloon catheter, 2af283 with lot 44391, were returned and analyzed.The data files showed four injections were performed on the date of the event with no system issue.Visual inspection showed that the catheter was intact with no apparent issues.The id at the distal end of the push button luer was 0.041 inches.Visual inspection under the microscope did not show any excessive glue at the proximal end of the guide wire lumen shaft and the luer interface.The inability to insert the achieve catheter has been reproduced.It was impossible to insert the returned achieve through the catheter.Achieve mapping test catheter get stuck at the balloon section.The catheter failed the performance test due to persistent system notice (b)(4) (leak detection) upon connection to the console.Pressure test revealed a leak through the guide wire lumen and distal outer vacuum lumen laser drilled holes.Dissection showed a guide wire lumen twist and breach proximal to the coil and leak path through the 0.5 psi check valve in the y-block.In conclusion, the balloon catheter, 2af283 with lot 44391, failed the performance test due to inability to insert the achieve catheter and persistent system notice (b)(4).The root causes of these symptoms are guide wire lumen twist and breach proximal to the coil, and leak path through the 0.5 psi check valve in the y-block.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 fluid in the catheter and stopped the injection.The balloon catheter was replaced with resolve.The case was completed with cryo.No patient complications have been reported as a result of this event.The 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: 7451568
• MDR Text Key: 106269969
• Report Number: 3002648230-2018-00246
• 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
• Report Date: 04/23/2018

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: 10/30/2019
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 44391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2018
• Initial Date Manufacturer Received: 04/21/2018
• Initial Date FDA Received: 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2017
• 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