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 Material Deformation (2976)

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

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

Event summary: upon visual inspection of balloon catheter 2af283 / 50862, results showed that the catheter was intact with no apparent issue.Smart chip verification showed that the catheter has been used for twelve injections.Performance test did not show any system notice.The catheter passed the performance test as per specification.Dissection showed that guide wire lumen kinked on 1.3940 inches from the tip of the catheter.The catheter failed the performance test due to kink on guide wire lumen.In conclusion, the reported (gwl kink) issue has been confirmed through testing.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 during a cryo ablation procedure, it was noted that the balloon shape was not as expected when inflated.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.On 2018-08-03: following analysis of the product/clinical data an out of specification finding was discovered.The balloon catheter was reassessed for reportability.

• 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: 7823793
• MDR Text Key: 118550544
• Report Number: 3002648230-2018-00586
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 02000012967731
• UDI-Public: 2000012967731
• Combination Product (y/n): N
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial
• Report Date: 08/28/2018

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: 04/04/2020
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 50862
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2018
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 08/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2018
• 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
• Patient Age: 68 YR