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 02/19/2018

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files and balloon catheter, 2af284 with lot number 79013 were returned and analyzed.The data files showed at least 20 injections were performed with multiple catheters on the date of the event.This returned balloon catheter showed, system notice (b)(4) ¿there is a problem with the injection process¿ on application 1, and system notice # (b)(4) ¿the balloon is not sufficiently inflated, balloon inflation pressure was not reached in time¿ on application 2 and 3.Visual inspection of the balloon catheter showed the devices were intact with no apparent issues.The catheter failed the performance test due to frost formation on the coaxial connector during the ablation cycle.Dissection and pressure test revealed a leak path through the catheter coaxial connector adhesive.There was also a guide wire lumen kink at 1.053 inches from the tip inside the balloons.In conclusion, the balloon catheter failed the returned product inspection due to leak path through the catheter coaxial connector and guide wire lumen kink.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that a cryoablation procedure was completed and upon return of the balloon catheter; it subsequently tested out of specification per the manufacturer's investigation.

• 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: 7554164
• MDR Text Key: 109623280
• Report Number: 3002648230-2018-00343
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2018

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: 11/17/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 79013
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/08/2018
• Initial Date FDA Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2017
• 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