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 02/20/2018

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files and balloon catheter with lot number 98903, were returned and analyzed.The data files showed at least eleven applications were performed with a different catheter without any issues or system notices on the date of event.System notice 50006 ¿the safety system has detected blood in the cath handle, stopped the injection and disabled the vacuum¿ was confirmed to have occurred multiple times on the date of the event.Visual inspection showed that the catheter had a kink under the balloons.The catheter passed the performance test and the electrical integrity as per specification; also, the impedance and pressure sensor readings were within specification.Dissection showed a guide wire lumen kink at 1.47 inches from the tip inside the balloons.Pressure test did not show leaks.In conclusion, the 50006-system notice was confirmed through the failure file analysis.The balloon catheter failed the returned product inspection due to a 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 blood in the catheter handle, the injection was stopped and the vacuum disabled.The balloon catheter was replaced with resolution.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.

Manufacturer Narrative

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
• 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: 7481393
• MDR Text Key: 107192374
• Report Number: 3002648230-2018-00282
• 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,Followup
• Report Date: 05/02/2018

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: 09/28/2019
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 98903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/02/2018
• Supplement Dates Manufacturer Received: 05/02/2018
• Supplement Dates FDA Received: 05/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2017
• 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