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 Problems Nonstandard Device (1420); Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

Event summary: the patient data files showed at least twenty-eight applications were performed with catheter 2af284 / 96138 and 2af284 / 32558 without any issue on the date of the event.Upon visual inspection of catheter 2af284 / 96138, results showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was used for four injections.The balloon catheter passed the functional and deflection test; no system notice triggered during functional test.Dissection showed a guide wire lumen kink at 1.38 inches from the tip inside the balloons.Pressure test did not show leaks.In conclusion, the reported deflection issue could not be confirmed through testing for returned product, but balloon catheter failed the inspection due to guide wire lumen kink.If information is provided in the future, a supplemental report will be issued.

Event Description

The balloon catheter subsequently tested out of specification per the manufacturer's investigation.

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; 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: 7764094
• MDR Text Key: 116907377
• Report Number: 3002648230-2018-00542
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 02000012679609
• UDI-Public: 2000012679609
• Combination Product (y/n): N
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2020
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 96138
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/05/2018
• 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