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 Air Leak (1008)

Patient Problems Low Blood Pressure/ Hypotension (1914); Nerve Damage (1979); ST Segment Elevation (2059)

Event Date 03/29/2018

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, after the initial left inferior pulmonary vein (lipv) ablation, st segment elevation was observed as well as a decrease in blood pressure.Noradrenalin was administered, and the patient¿s blood pressure and st segment recovered.It was later indicated that phrenic nerve palsy (pnp) was observed.A double stop technique was performed and the pnp recovered.Following the case, the physician suspected that the events were caused by the micro bubble in the balloon catheter surface.The case was able to be completed with cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed seven applications were performed the date of the event using balloon catheter, 2af284 with lot number 06288 without any system notice.The balloon catheter was not returned for analysis; the product could not be investigated.The reported adverse events are clinical issues encountered during the procedure that cannot be confirmed through data analysis.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: 7463467
• MDR Text Key: 106568525
• Report Number: 3002648230-2018-00255
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 06288
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2017
• 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 Outcome(s): Required Intervention