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 Problems Material Deformation (2976); Material Integrity Problem (2978)

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

Event Date 05/21/2018

Event Type  malfunction  

Manufacturer Narrative

Event summary: the patient data files showed at least twelve applications were performed with catheter 2af284 / 70918 on the date of the event and system notice #(b)(4) ¿blood detection¿ was triggered on the application ten and twelve.Failure files also confirmed the system notice of the # (b)(4) ¿fluid detection in catheter¿ on the date of the event.Visual inspection of 2af284 / 70918, results showed the traces of the blood inside the balloon.Smart chip verification indicated the catheter was used for twelve injections.System notice (# (b)(4)) was received indicating that ¿the safety system detected fluid in the catheter and stopped the injection immediately¿ appears upon connecting the catheter to the console.Unable to perform the performance test due to persistent system notice # (b)(4).Dissection showed a guide wire lumen kink and breach at 1.41 inches from the tip inside the balloons.In conclusion, the reported system notices (# (b)(4)) indicating that ¿the safety system detected blood in the catheter handle, the injection was stopped and the vacuum disabled¿ and (# (b)(4)) ¿the safety system has detected fluid in the catheter and stopped the injection¿ were confirmed through data file analysis and through testing.The balloon catheter failed the returned product inspection due to a guide wire lumen breach and kink.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: 7834448
• MDR Text Key: 119042267
• Report Number: 3002648230-2018-00598
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 02000012557063
• UDI-Public: 2000012557063
• 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: 02/05/2019
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 70918
• 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: 02/05/2018
• 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