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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2020

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files and 2af283 balloon catheter with lot 56473 were returned and analyzed.The data files showed the balloon catheter was used for at least six applications on the date of the event without issue.The data files also showed system notice #50005 (the safety system has detected fluid in the catheter and stopped the injection) triggered several times on the date of the event.Visual inspection showed that the catheter was intact with no apparent issues.The balloon catheter failed the performance test due to system notice #50005 upon application of the vacuum.A fluid was seen in the coaxial connector and the pressure test showed a leak through the tip.Catheter dissection and pressure testing showed a guide wire lumen breach.Further analysis showed a guide wire lumen breach, twist, and kink at the balloon segment in several points (1.35 , 1.36 and 086 inches) proximal from the tip.In conclusion, the balloon catheter failed the returned product inspection due to a guide wire lumen twist, breach and kink.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 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: 10726964
• MDR Text Key: 212764755
• Report Number: 3002648230-2020-00561
• 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: 10/23/2020

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: 06/05/2022
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 56473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 10/02/2020
• Initial Date FDA Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/05/2020
• 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