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 02/06/2018

Event Type  malfunction  

Manufacturer Narrative

Event summary: the patient data files showed at least three applications were performed with catheter 2af283 / 43656-63 on the date of the event and system notice (#50032) was received indicating that the safety system detected a compromised outer vacuum was triggered on the application two and three.Data files also showed at least four more applications were performed with catheter 2af283 / 44348-88 and system notice (#50032) was received indicating that the safety system detected a compromised outer vacuum was triggered on the application 1,2 and 3.Additionally, twelve more applications were performed with catheter 2af283 / 43656-21 with no system notice.Visual inspection of catheter 2af283 / 44348-88 showed the device handle was opened.Smart chip verification indicated the catheter was used for four injections.The catheter passed the performance test; electrical integrity and impedance were also within specification.Dissection/pressure testing did not show any leaks or traces of liquid/blood inside the catheter.Dissection showed a guide wire lumen kink at 1.08 inches from the tip inside the balloons.In conclusion, the reported issue (system notice #50032) confirmed through data analysis and testing for the returned products.The balloon catheter failed inspection due to opened handle and guide wire lumen kinked.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, a system notice was received indicating that the safety system detected a compromised outer vacuum.The balloon catheter was replaced, but the issue persisted.Additionally, another system notice was received indicating that the safety system detected a compromised outer vacuum.The electrical umbilical cable was disconnected and reconnected without resolve.The balloon catheter was then replaced again, and the auto connection box was also replaced with resolve.The case was completed with cryo.No patient complications have been reported as a result of this event.On 2018-05-01: upon return and analysis of the balloon catheter, the catheter tested out of specification.

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: 7483687
• MDR Text Key: 107981622
• Report Number: 3002648230-2018-00285
• 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,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,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: 11/03/2019
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 44348
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/01/2018
• Initial Date FDA Received: 05/03/2018
• Supplement Dates Manufacturer Received: 07/09/2018
• Supplement Dates FDA Received: 07/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2017
• 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: 56 YR