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 Problem Air Leak (1008)

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

Event Date 08/03/2017

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 cryo ablation procedure, when the sheath was flushed continuously, an ¿occlusion alarm¿ (alarm from the infusion pump) was triggered.A sheath port check confirmed air ingress.An attempt was made to perform air aspiration but a syringe was unable to be pulled out.The balloon catheter was thus extracted once and air aspiration was performed.Then, the balloon catheter was inserted again and no air was confirmed in the product.Ablation was started but the occlusion alarm was triggered multiple times.The procedure continued and was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files for the date of the event were returned and analyzed.The files show at least ten applications with balloon catheter, 2af284 lot 17118, and eight applications with electrophysiology (ep) catheter, 239f3 lot 15994.No system notices or issues were noted.Further results pending the returned product analysis.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Event summary: upon visual inspection of the balloon catheter 2af284 / 17118-12, results showed that the catheter was intact with no apparent issue.Smart chip verification showed that the catheter has been used for ten injections.The catheter passed the performance test; electrical integrity and impedance were also within specification.No kink was observed either along the shaft or the guide wire lumen.In conclusion, the reported issue (unable to aspirate) has been not confirmed through the testing and data analysis.The balloon catheter passed the returned product inspection.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; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 6827592
• MDR Text Key: 83886844
• Report Number: 3002648230-2017-00476
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 11/21/2017

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: 05/15/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 17118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2017
• Initial Date FDA Received: 08/29/2017
• Supplement Dates Manufacturer Received: 09/15/2017; 10/27/2017
• Supplement Dates FDA Received: 10/03/2017; 11/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2017
• 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
• Treatment: 4FC12 SHEATH