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 Air Leak (1008)

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

Event Date 07/19/2016

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryoablation procedure while the balloon catheter was being prepared, the physician noted "a lot of bubbles." it was further reported that a system notice was then received indicating that the safety system detected a compromised outer vacuum.The cables were disconnected and reconnected, and the console was rebooted, but the message continued.The balloon catheter was then replaced and the issue was resolved.

Manufacturer Narrative

Product event summary: the balloon catheter, 2af283 with lot 56805, was returned and analyzed.Visual inspection of the catheter showed the device was intact with no apparent issues.Smart chip verification indicated that the catheter was not used.The catheter passed the performance test and electrical integrity test as per specification; the impedance was also within specification.The 12218 (outer vacuum compromised) system notice received could be related to the coaxial umbilical connection either to the catheter or to the console.Aspiration and flushing was able to be done once the balloon was in and out of the sheath.The outer diameter (od) of the balloon proximal bonding was within specification.Insertion and retraction tests were performed without friction.Dissection and pressure tests did not show any leaks or traces of liquid or blood inside the catheter, on the shaft, or on the guide wire lumen.In conclusion, the reported issue of air ingress during aspiration and system notice indicating outer vacuum compromised could not be confirmed through testing.The device passed the returned product inspection as per specification.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5876096
• MDR Text Key: 52101148
• Report Number: 3002648230-2016-00321
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2017
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 56805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2015
• 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
• Patient Age: 46 YR
• Patient Weight: 90