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 Material Deformation (2976)

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

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

Event summary: the patient data files showed at least three applications were performed with catheter 2af284 / 49772 on the date of the event with no system notice or any issues.Patient data files also showed at least eight more applications were performed with catheter 2af284 / 59973 with no system notices or issues.Upon visual inspection of catheter, 2af284 / 49772, results showed that the catheter was intact with no apparent issue.Smart chip verification showed that the catheter has been used for three injections.The catheter failed the performance test due to system notice of ((b)(4)) indicating that the refrigerant delivery path was obstructed.The catheter passed the deflection test as per specification.Dissection showed that guide wire lumen kinked on 1.4140 inches from the tip of the catheter.The catheter failed the performance test due to kink on guide wire lumen.In conclusion, the reported (balloon catheter guidewire bent/kink) issue has been confirmed through testing but not confirmed through the data analysis.The balloon catheter failed the returned product inspection due to guide wire lumen kink.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that prior to cryo ablation procedure, during set up, after deflating the balloon, it was observed that the tip of the balloon catheter was bent.The balloon catheter was then replaced.The procedure continued 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: 7821241
• MDR Text Key: 118550426
• Report Number: 3002648230-2018-00576
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 02000013301865
• UDI-Public: 2000013301865
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 08/27/2018

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 Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 49772
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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