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 Mechanical Problem (1384); Retraction Problem (1536)

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

Event Date 10/09/2014

Event Type  malfunction  

Event Description

Information received by medtronic indicated that system notice message 50032 (the safety system has detected a compromised outer vacuum) occurred during the procedure.The push button of the catheter was not pressed and therefore the user was unable to retract the cryoablation catheter into the sheath with ease.The user reported that the catheter was damaged during the attempts to retract the catheter into the sheath.The manual retraction kit was used and the catheter was removed from the patient without any issues.The case was aborted leaving one of the veins not isolated.There was no patient injury.Reportable based on analysis completed 12/03/2014.

Manufacturer Narrative

The returned device was visually inspected and functionally tested.The reported system notice #50032 issue has been confirmed through data analysis.Visual inspection showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was used for 22 injections.Upon connecting the catheter to console, system notice #50005 ¿fluid in catheter¿ was triggered.Dissection and pressure test revealed guide wire lumen kink at 0.76¿, 0.91¿ and 1.01 inches proximal from the tip and also revealed a guide wire lumen breach at.76 inches from the tip.The balloons integrity was intact; no breach observed.

• 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: 4355965
• MDR Text Key: 5179199
• Report Number: 3002648230-2014-00226
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 12/03/2014

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: 04/01/2016
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 82320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 12/23/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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: 00066 YR
• Patient Weight: 86