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 Air Leak (1008)

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

Event Date 05/04/2016

Event Type  malfunction  

Event Description

It was reported that during a cryoablation procedure, there was a leak in the sheath.After the insertion of the balloon catheter into the sheath, the physician was able to aspirate air over the side port of the sheath.They made several attempts but ended up changing the sheath without resolve.The physician proceeded to change the balloon catheter.The case was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Correction: product event summary: the arctic front advance balloon catheter, 2af283 with lot number 23059, was returned and analyzed.Visual inspection of the catheter showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was not used.The catheter passed the performance and electrical integrity test as per specification.The reported air ingress could not be reproduced.In conclusion, the arctic front advance balloon catheter, 2af283 with lot number 23059, passed the returned product inspection as per 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 H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe claire,qc H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5751827
• MDR Text Key: 48292566
• Report Number: 3002648230-2016-00255
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 06/03/2016

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: 02/16/2018
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 23059
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/03/2016
• Initial Date FDA Received: 06/27/2016
• Supplement Dates Manufacturer Received: Not provided; 09/21/2016
• Supplement Dates FDA Received: 09/21/2016; 09/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2016
• 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 Outcome(s): Other