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

Model Number AFAPRO28

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

Patient Problems Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Cardiac Perforation (2513); Cough (4457)

Event Date 12/27/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 2ach20 mapping catheter; 4fc12 sheath if information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, the patient's blood pressure decreased. echocardiogram showed cardiac tamponade.Tracheal intubation and drainage were performed which helped stabilize the blood pressure.However, the blood pressure decreased again during hemostasis.Cardiac massage and drainage were resumed which helped remove the tamponade.The patient was transported to the intensive care unit (icu) and the case was completed with cryo.The physician stated that this could be because that the "rv" catheter was inserted too deep.The patient was coughing during the case so the catheter was "scratched".Hemorrhaging was also observed. no further patient complications have been reported as a result of this event.2023-01-25, 15:36:47: it was also reported that the patient underwent pulmonary vein isolation (pvi) followed by cavotricuspid isthmus isolation (cti).The patient was coughing during the pvi portion of the procedure, but not during the cti portion of the procedure.It was also reported that the cardiac massage was performed outside of the patients chest, meaning chest compressions were performed.It was also reported that the left inferior pulmonary vein (lipv) had been perforated prior to the hypotension, hemorrhage, and tamponade.The perforation was not noticed while the patient was in the operating room.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: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16244248
• MDR Text Key: 308143713
• Report Number: 3002648230-2023-00043
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 18423
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Date Device Manufactured: 06/30/2022
• 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: 239F5 ELECTROPHYSIOLOGY (EP) CATHETER,
• Patient Outcome(s): Hospitalization; Required Intervention; Life Threatening