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 Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Low Blood Pressure/ Hypotension (1914); Nausea (1970); Perforation (2001); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 02/07/2017

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure, the patient experienced nausea, which the physician commented was caused by either occlusion in the left pulmonary vein or a medication.The nausea caused the patient to move, resulting in decreased blood pressure and a pericardial effusion.Following ablation in the right superior pulmonary vein (rspv) pericardial effusion was confirmed through transthoracic echocardiography (tte).Drainage was performed and approximately 80 cc of fluid was aspirated.The patient was then moved to the intensive care unit (icu) the patient recovered and was discharged as scheduled.The physician commented that the tamponade was probably caused when the patient moved due to nausea and the perforation occurred by catheter in the right ventricular (rv) at that time.The physician also stated that the event was not directly related to the medtronic products.

Manufacturer Narrative

Product event summary: data files were returned and analyzed.Data files showed that four injections were performed with the catheter without any system notice on the date of the event.In conclusion, the case was related to a clinical issue and the device was not returned for investigation.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

No further patient complications have been reported as a result of this event.

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 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: 6378274
• MDR Text Key: 69091982
• Report Number: 3002648230-2017-00106
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100010
• 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: 04/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 45844
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/03/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/31/2016
• 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): Life Threatening; Required Intervention