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

Model Number 2AF283

Device Problems Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 07/25/2018

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, it was observed that the guidewire lumen port was broken when opening the packaging.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.

Manufacturer Narrative

Event summary: visual inspection of balloon catheter, 2af283 / 67346, showed that the luer was broken.Smart chip verification indicated the catheter was used not.Without reprogramming the catheter, it was connected to the console and no system notices were received; catheter was recognized.The catheter passed electrical integrity test and the performance as per specification.In conclusion, the reported (guide wire lumen broken out of package) was confirmed through testing.The catheter failed the product returned inspection due to a broken luer.If information is provided in the future, a supplemental report will be issued.

Event Description

It was later reported that the procedure was completed cryo.

• Brand Name: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
• Type of Device: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• Manufacturer (Section G): MEDTRONIC, INC.; 710 medtronic parkway; minneapolis MN 55432
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7803930
• MDR Text Key: 117833270
• Report Number: 3002648230-2018-00563
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/20/2020
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 67346
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2018
• 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