MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE PRO CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number AFAPRO28

Device Problems Material Integrity Problem (2978); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/19/2020

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files and balloon catheter afapro28 with lot number 53312 were returned and analyzed.The data files showed that the date on the file was 1 january 2001.The battery on the cpu may be depleted.The files also showed at least six applications with the returned catheter were performed without any system notice.In another file showed that system notice 50005 was received ¿the safety system has detected fluid in the catheter and stopped the injection.¿ visual inspection of the catheter showed that the traces of blood inside the balloon catheter and the coaxial connector.Smart chip verification indicated the catheter was not used for any injection.The catheter failed the performance test after triggering system notice #50005 ¿the safety system has detected fluid in the catheter and stopped the injection¿ upon connection to the console.Dissection showed the traces of the blood inside the handle and the pressure test revealed the guide wire lumen was breached and kinked at 1.209 and 2.49 inches from the tip.The compatibility issue was reproduced with the returned mapping catheter and as well as a test mapping catheter due to the kinks on the guide wire lumen.In conclusion, the balloon catheter failed the returned product inspection due to the guide wire lumen kink and breach.If information is provided in the future, a supplemental report will be issued.

Event Description

After a completed case, the balloon catheter subsequently tested out of specification per the manufacturer's investigation.

• Brand Name: ARCTIC FRONT ADVANCE PRO 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10521504
• MDR Text Key: 209811064
• Report Number: 3002648230-2020-00477
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/11/2020

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: 01/05/2022
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 53312
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2020
• Initial Date Manufacturer Received: 08/21/2020
• Initial Date FDA Received: 09/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2020
• 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