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 Rupture (1546); Device Operates Differently Than Expected (2913)

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

Event Date 04/21/2015

Event Type  malfunction  

Manufacturer Narrative

The information submitted reflects all relevant data received.If additional relevant information is received, a supplemental report will be submitted.Product event summary: the balloon catheter and data files were returned and analyzed.The data files confirmed the system notice that indicated that the safety system detected a compromised outer vacuum (#(b)(4)) at injection one.Visual inspection of the catheter showed that the device was intact with no apparent issues.The catheter failed the performance test due to a system notice that indicated that the safety system detected fluid in the catheter and injection was stopped (#(b)(4)).Dissection and pressure testing of the catheter revealed a double balloon breach.In conclusion, the reported system notices that indicated that the safety system detected a compromised outer vacuum and that the safety system detected fluid in the catheter and the stopped the injection were confirmed through testing and data analysis.The catheter failed the returned product inspection due to a double balloon breach.

Event Description

It was reported that during a cryo ablation procedure, multiple system notices had occurred indicating that the safety system detected a compromised outer vacuum and fluid was detected in the catheter and injection was stopped.It was noted that the physician reported that the balloon had ruptured.There was no visible blood.The balloon catheter was replaced and the procedure was completed with cryo.The device subsequently tested out of specification upon the manufacturer¿s analysis.No patient complications have been reported as a result of this event.

• 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; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5188292
• MDR Text Key: 30322235
• Report Number: 3002648230-2015-00381
• Device Sequence Number: 1
• Product Code: OAE
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2015
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 91243
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2014
• 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