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 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files for the date of the reported event and balloon catheter, 2af283 with lot 30381, were returned and analyzed.The data files showed two unrelated system notices were received at the date of the case.Visual inspection showed that the balloon catheter was intact with no apparent issues.The id of the push button luer was equal to 0.045 inches.Visual inspection under the microscope did not shows any debris at the proximal end of the guide wire lumen shaft and the luer.The proximal end of the shaft was perfectly circular.No blockage was observed.The catheter passed the deflection test as per specification.The dissection testing confirmed a guide wire lumen kink on 1.389 inches from the distal point of the catheter¿s tip.The reported issue (balloon shape and debris in balloon) was confirmed through testing but not confirmed through data analysis.In conclusion, the balloon catheter, 2af283 with lot 30381, failed the returned product inspection due to a guide wire lumen kink.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 balloon shape was not round and difficult to position.Additionally, and unknown system notice was received indicating the balloon catheter needed to be replaced.It was noted that a filament was visible at the center of the balloon.The balloon catheter was replaced.The case was completed with cryo.No patient complications have been reported as a result of this event.Incoming information indicated that it was the injection tube of the balloon catheter that was observed in the center of the balloon.The "filament" that was observed was the balloon catheter kinked due to difficult manipulation.The balloon catheter subsequently tested out of specification per the manufacturer's investigation.

• 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: 7241057
• MDR Text Key: 99081221
• Report Number: 3002648230-2018-00066
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2018

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: 03/21/2019
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 30381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2018
• Initial Date FDA Received: 02/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2017
• 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: 53 YR