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 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

Event summary: the returned patient data files showed at least four applications were performed with catheter 2af284 / 71643 on the date of the event system notice # (b)(4) was triggered at the second, third, and fourth applications on the event date.The returned data files also showed at least two applications were performed with catheter 2af284 / 83566 on the date of the event.Additionally, the returned data files showed at least seven applications were performed with catheter 2af284 / 83566 on the date of the event.The failure file showed a system notice (# (b)(4)) indicating that the safety system detected fluid in the catheter and stopped the injection was triggered on the event date.Visual inspection of balloon catheter 2af284 / 83566, results showed traces of blood inside the inner and outer balloon.Smart chip verification indicated the catheter was used for two injections.System notice (# (b)(4)) was received indicating that the safety system detected a compromised outer vacuum and was triggered during the ablation test.Dissection showed also the trace of blood inside the handle, pressure testing showed breach on both balloons.In conclusion, system notices (# (b)(4)) ¿the safety system has detected a compromised outer vacuum¿ and (# (b)(4)) ¿the safety system has detected fluid in the catheter and stopped the injection¿ were confirmed through bin file analysis and through testing.Balloon catheter failed the returned product inspection due to double balloon breach.If information is provided in the future, a supplemental report will be issued.

Event Description

The device was returned to the manufacturer, analyzed, and tested out of specification.

• 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: 7834908
• MDR Text Key: 118884411
• Report Number: 3002648230-2018-00600
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 02000013142997
• UDI-Public: 2000013142997
• 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
• Type of Report: Initial
• Report Date: 08/30/2018

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: 04/18/2019
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 83566
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2018
• Initial Date Manufacturer Received: 08/05/2018
• Initial Date FDA Received: 08/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2018
• 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