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 Problems Fluid/Blood Leak (1250); Difficult To Position (1467); Device Displays Incorrect Message (2591)

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

Event Date 01/13/2014

Event Type  malfunction  

Event Description

Information received by medtronic indicated that the user was not able to maneuver the mapping catheter into the cryoablation catheter after the first ablation.While maneuvering the catheter, the user received system notice message 50005 (the safety system has detected fluid in the catheter and stopped the injection).The catheter was replaced and the cryoablation procedure was completed.When the device was returned, pressure testing revealed a leak through the guide wire lumen.Reportable based on analysis completed on (b)(4) 2014.

Manufacturer Narrative

The returned device and was visually inspected and functionally tested.Failure files confirmed system notice message 50005 "leak detection" for the date of case.Smart chip verification indicated the catheter was not used.Visual inspection showed that the device was intact with no apparent issues.Pressure test revealed a leak through the guide wire lumen, however, the balloons integrity was intact.Dissection showed a guide wire lumen breach and kink at 1.06 inches proximal from the tip.An internal capa has been initiated to investigate the condition of guide wire lumen breach found.The inability to insert the achieve mapping catheter was not reproduced.This report will be recorded and trended.

• 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,qc H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland,qc H9H 5H3; CA H9H 5H3
• Manufacturer Contact: voula radiotis ; 16771 chemin ste-marie; kirkland,qc H9H 5-H3 ; CA H9H 5H3 ; 5146941212
• MDR Report Key: 3688270
• MDR Text Key: 4242234
• Report Number: 3002648230-2014-00048
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2015
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2013
• 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