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 01/24/2018

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed at least fourteen applications were performed with the catheter for the date of the event.Also, a system notice- (b)(4) (the safety system has detected fluid in the catheter and stopped the injection) unrelated to the reportable malfunction was confirmed.The physical product has not been returned.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, an "unusual bend" was observed just proximal to the balloon, indicating a guide wire lumen kink.The balloon catheter was replaced with resolve, and the case was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: patient data files showed at least fourteen applications were performed with balloon catheter 2af284/08776-04 on the date of the event and system notice (#50005) was received indicating that the safety system detected fluid in the catheter and stopped the injection was confirmed in application number fourteen.Additionally, the data files showed at least three applications were performed with catheter 2af284 /08776-90 without any issue on the date of the event.Upon visual inspection of balloon catheter 2af284 / 08776-04, results showed the device was intact with no apparent issue.Verification of the smart chip file showed that this catheter was used for fourteen injections.The catheter passed the performance test; electrical integrity and impedance were also within specification.Dissection showed that guide wire lumen kinked on 1.3420 inches from the tip of the catheter.The catheter failed the performance test due to kink on guide wire lumen.In conclusion, the reported issue system notice #50005 has been not confirmed through testing but confirmed through the data analysis.The reported issue of guidewire lumen kink 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.

• 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: 7284844
• MDR Text Key: 100577455
• Report Number: 3002648230-2018-00104
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 00643169753693
• UDI-Public: 00643169753693
• 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,Followup
• Report Date: 04/03/2018

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: 03/09/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 08776
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/20/2018
• Supplement Dates Manufacturer Received: 03/07/2018
• Supplement Dates FDA Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2017
• 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
• Patient Age: 69 YR
• Patient Weight: 106