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 Problem Infusion or Flow Problem (2964)

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

Event Date 10/30/2014

Event Type  malfunction  

Event Description

During a cryoablation procedure, the cryoconsole showed system notice message 50005 (the safety system has detected fluid in the catheter and stopped the injection).The catheter was replaced and the procedure was completed.There were no patient symptoms or complications related to the event.Reportable based on analysis completed (b)(4) 2014.

Manufacturer Narrative

The returned device was visually inspected and functionally tested.Bin files were reviewed and confirmed the system notice 50005 ¿leak detection¿ for the date of event.Visual inspection showed blood between balloons.Smart chip verification indicated the catheter was used for 11 injections.The catheter failed the performance test due to system notice #50005 upon connection.The reported issue has been confirmed through testing.The catheter failed the returned product inspection due to guide wire lumen breach.Pressure testing showed a leak through the guide wire lumen, the balloons integrity was intact, no breach observed.Dissection showed a guide wire lumen breach at 1.52 inches proximal from the tip.

• 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: 4402268
• MDR Text Key: 5368957
• Report Number: 3002648230-2015-00005
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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: 12/12/2014

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: 09/01/2016
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 80516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2014
• Initial Date FDA Received: 01/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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
• Patient Age: 00039 YR