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 Problem Kinked (1339)

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

Event Date 12/01/2017

Event Type  malfunction  

Manufacturer Narrative

Event summary: the patient data files showed at least four applications were performed with catheter 2af284 / 43644-60 without any issues or system notices on the date of event.Data files also showed at least eight applications were performed with catheter 2af284 / 85287-74 without any issues or system notices on the date of event.Upon visual inspection of catheter 2af284 / 43644-60 results showed the device was intact with no apparent issues.Smart chip verification showed the catheter was used for four injections.The id of the push button luer was blocked (spec: 0.045").The lab test mapping catheter could not be successfully inserted into the catheter.Dissection showed excessive glue at the proximal end of the guide wire lumen shaft and the luer also guide wire lumen shaft was kinked on 1.3030 inches from the tip of the catheter.Therefore, the inability to insert the achieve has been reproduced.Catheter failed the performance test due to kink on guide wire lumen and excessive glue at the proximal end of the guide wire lumen shaft and the luer.In conclusion, the reported issue has been confirmed through testing but not confirmed through the data analysis.The balloon catheter failed the returned product inspection due to excess glue in push button luer and 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, the balloon catheter shaft appeared to be kinked within the section inside the balloon.Additionally, difficulty was observed when attempting to remove the balloon catheter from the sheath.The catheter was replaced with resolve, and the case was completed with cryo.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: 7251766
• MDR Text Key: 99802738
• Report Number: 3002648230-2018-00078
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/08/2018

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: 08/16/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 43644
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2017
• 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