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 Kinked (1339); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

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

Event Date 06/02/2015

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 catheter, 2af284 / 46026-82, and data files were returned.Data file analysis showed at least five injections were performed with the returned catheter.The system notices observed within the data files were associated with another returned product.Smart chip verification indicated the catheter was used for five injections.Visual inspection of the catheter showed the inner balloon had traces of blood inside; there was not any blood inside the catheter handle.Pressure tests revealed a leak through the guide wire lumen but the balloon integrity was intact and no breach was observed.Dissection showed a guide wire lumen twist and breach at 0.87 inches proximal from the tip.Visual inspection under microscope showed the detached parts of the associated mapping catheter had been stocked inside the guide wire lumen at the tip of the catheter on the place of the breach.(b)(4).

Event Description

It was reported that during a cryo ablation procedure a system notice indicating the safety system detected fluid in the catheter and stopped the injection occurred.The balloon catheter was removed and the physician realized there was an "issue" with the mapping catheter and the sheath was also kinked.The catheters and sheath were replaced.Next, a system notice indicating the refrigerant delivery path is obstructed occurred after replacement of all the disposable products.Another system notice indicating there was a problem with the refrigerant process occurred and the coaxial umbilical and electrical umbilical were replaced with no resolve.A new console was then used which displayed a system notice indicating the time usage limit allowed for the catheter had expired.The time on the console was changed and the procedure was completed with cryo.Upon manufacturer's analysis the balloon catheter tested out of specification.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: 5036749
• MDR Text Key: 25146439
• Report Number: 3002648230-2015-00248
• 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
• Report Date: 07/31/2015

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: 04/01/2016
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 46026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/27/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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