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 Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Transient Ischemic Attack (2109)

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

The data files were returned and analyzed.The data files showed at least eight applications were performed with the afapro28 balloon catheter with an unknown lot number without any issue on the date of the event.In conclusion, the reported transient ischemic attack (tia) and leg movement difficulty occurred after the procedure was completed.There is no indication that the adverse event is related to the performance or a malfunction of the product.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that following a cryo ablation procedure, the patient had a transient ischemic attack (tia).The patient had difficulty moving their leg, which later significantly improved.The patient was hospitalized.No further patient complications have been reported as a result of this event.

• 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: 10785805
• MDR Text Key: 214579793
• Report Number: 3002648230-2020-00569
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: 4FC12 SHEATH, 2ACH20 MAPPING CATHETER
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR
• Patient Weight: 80