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 Kinked (1339)

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

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that during a cryo ablation procedure, the internal lumen of the balloon kinked.It was noted that the balloon may have been compromised.The catheter continued to be used and the procedure was completed with cryo.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: patient files showed at least five injections were performed with catheter 2af283 / 05492-58 on the date of the event, system notice #50012 was received indicating that the refrigerant delivery path was obstructed was triggered on application #1.In conclusion, the reported kinked lumen was not confirmed through the data analysis.Pending results of the analysis is on the return products/field service engineer report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

Product event summary: the device was returned and analyzed.Visual inspection of the catheter showed a kink on guide wire lumen in the balloon segment and 1.43 inches proximal from the tip.Smart chip verification indicated that the catheter was used for 5 injections.A persistent system notice indicating that the safety system detected fluid in the catheter and stopped the injection (sn#50005) was triggered when the catheter was connected to the console.In conclusion, the reported kink and balloon compromised issue was confirmed through testing.The catheter failed the returned product inspection due to a double balloon breached and guide wire lumen kink.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: 7238668
• MDR Text Key: 99000627
• Report Number: 3002648230-2018-00065
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/28/2018

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: 07/14/2019
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 05492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/02/2018
• Supplement Dates Manufacturer Received: 01/19/2018; 02/27/2018; 03/28/2018
• Supplement Dates FDA Received: 02/14/2018; 03/22/2018; 03/28/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/14/2017
• 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
• Patient Age: 78 YR