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 07/22/2020

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files and afapro28 balloon catheter with lot 22253 were returned and analyzed.The data files showed nine applications were performed with the returned catheter on the date of the event.The data files showed a persistent 50005 system notice (indicating that the safety system detected fluid in the catheter and stopped the injection).Visual inspection of the balloon catheter showed the device was intact without any issues.Smart chip verification showed that the catheter was used for nine applications on date of event.The catheter failed performance test due to system notice 50005 upon application of the vacuum.Pressure testing showed a leak though the tip.Further dissection and pressure testing showed a guide wire lumen breach.Further analysis showed a guide wire lumen breach and kink at balloon segment.In conclusion, the balloon catheter failed the returned product analysis due to a 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: 10508377
• MDR Text Key: 209811389
• Report Number: 3002648230-2020-00471
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 00763000245436
• UDI-Public: 00763000245436
• 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: 09/09/2020

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: 12/01/2020
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 22253
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2020
• Initial Date Manufacturer Received: 08/18/2020
• Initial Date FDA Received: 09/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2019
• 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