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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem ST Segment Elevation (2059)

Event Date 06/27/2019

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files and balloon catheter, 2af284 with lot number 46523, were returned and analyzed.The data files showed that at least seven applications were performed with an unreturned balloon catheter on the date of the event without any issue.Visual inspection of the returned balloon catheter showed the device was intact with no apparent issues.Smart chip verification indicated the catheter was used for six applications.The balloon catheter passed the performance test and electrical integrity as per specification; impedance was also within specification.The analysis did not identify any potential cause for the reported adverse event during the case.In conclusion, clinical issues were encountered during the procedure.The balloon catheter passed the returned product inspection as per specification.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryoablation procedure, the st segment was elevated after the completion of the right superior pulmonary vein (rspv) ablation.Medication was administered and the st elevation recovered.Following the next ablation, st elevation was observed again, and was able to recover.The case was completed with cryo.No further patient complications have been reported as a result of this event.

• 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: 8812211
• MDR Text Key: 151745596
• Report Number: 3002648230-2019-00516
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 46523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2019
• 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
• Patient Outcome(s): Required Intervention