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 Kinked (1339)

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

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

Event summary: the patient data files confirm system notice (# (b)(4)) indicating that the refrigerant delivery path was obstructed in application number six with the catheter 2af284/00143-84 on the date of the event.The data files showed at least seven applications were performed with this catheter.All other applications were non-sustained.Additionally, the data files showed at least nine applications were performed with catheter 2af284 /12130-31 without any issue on the date of the event.Visual inspection of catheter 2af284 / 00143-84, results showed that the catheter was not intact with guide wire lumen kink.Smart chip verification showed that the catheter has been used for seven injections.Dissection showed a guide wire lumen kink at 1.024 inches (26 mm) from the tip of the balloon.The catheter failed the test due to a leak at injection line coax connector adhesive of catheter¿s handle as the result of minor frost and the guide wire lumen kink.In conclusion, the reported (50012 system notice) issue has been not confirmed through testing but confirmed though the data analysis.The reported (kink catheter) issue has been confirmed through the testing but not confirmed through the data analysis.The catheter failed the returned product inspection due to guide wire lumen kink and leak at the injection line of coax connector adhesive of catheter as the result of the minor frost.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 catheter appeared to be bent and kinked.The catheter was used as it was.Then, a system notice had occurred indicating that the refrigerant delivery path was obstructed.Since the balloon shaft was still bent, both the balloon catheter and mapping catheter were replaced with resolve.The procedure was completed with cryo.No patient complications have been reported as a result of this event.On 2018-01-19: following analysis of the product, an out of specification finding was discovered.The pli was reassessed for reportability.

• 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: 7247846
• MDR Text Key: 99243392
• Report Number: 3002648230-2018-00076
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2018

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: 05/08/2018
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 00143
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/19/2018
• Initial Date FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2017
• 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