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 05/05/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that at the end of a cryo ablation procedure, upon removing the catheter from the patient, the distal lumen inside the balloon catheter did not look straight.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/ 41552, showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was used for seventeen applications on the date of the event.The balloon catheter passed the performance test as per specification.The catheter did not pass the deflection test as dissection showed a guide wire lumen is bent inside the balloons at 1.37 inches from the tip of the catheter.In conclusion, the reported issue (gwl kink, deflection issues) were confirmed through testing but not through data analysis.The balloon catheter failed the returned product inspection due to a guidewire lumen bend.If information is provided in the future, a supplemental report will be issued.

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: 7516575
• MDR Text Key: 108371204
• Report Number: 3002648230-2018-00315
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 07/09/2018

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: 03/25/2020
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 41552
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2018
• Initial Date FDA Received: 05/15/2018
• Supplement Dates Manufacturer Received: 06/11/2018; 07/09/2018
• Supplement Dates FDA Received: 07/02/2018; 07/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2018
• 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