MAUDE Adverse Event Report: MPRI 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 Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Pulmonary Edema (2020); Vascular Dissection (3160)

Event Date 02/21/2023

Event Type  Death  

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, another manufacturer's guidewire was advanced into the superior vena cava (svc).The sheath and the integrated dilator /needle were advanced over the guide wire and resistance was felt.Fluoroscopy was performed and identified that the resistance occurred at the femoral head.The guidewire, sheath and the integrated dilator/needle were removed.It was observed that the guidewire was kinked.A second attempt was made using another manufacturer's super stiff guidewire.The guidewire advanced into the superior vena cava (svc).The sheath and the integrated dilator /needle were backloaded over the guide wire and resistance was felt at the femoral head.Again, the guidewire, sheath and the integrated dilator/needle were removed.It was observed that the guidewire was kinked.Another guidewire was used and advanced into the right femoral vein.The guidewire began to track in a different direction, away from the main body of the femoral vein and would not advance into the superior vena cava (svc).The physician requested another manufacturer's guidewire and a long sheath.With effort, the guide wire was advanced into the superior vena cava (svc).The physician decided to switch to the left femoral vein due to the venous access issues in the right fem oral vein.Another manufacturer's guidewire, the sheath and the integrated dilator /needle were advanced into the heart and the superior vena cava (svc) and performed the transseptal puncture without any issues.The patient was hemodynamically stable throughout the case.The balloon catheter and mapping catheter were removed.While the physician was preparing another manufacturer's radiofrequency (rf) catheter to ablate the left atrial flutter, the patient's blood pressure dropped.The patient went into a ventricular fibrillation arrest and coded.Cardiopulmonary resuscitation was performed until heart rate and blood pressure returned, and a blood transfusion was given.A cardiac catheterization was performed and it confirmed that the coronary arteries were not in a condition to cause the ventricular fibrillation arrest.A heart pump was placed in the right femoral artery.The patient was stable but it appeared that the blood pressure and heart rate were decreasing.Due to the issues with the right femoral access, a venogram was performed.A dissection was confirmed near the femoral head of the right femoral vein.A balloon was inserted to stabilize the bleed, and then a stent was placed in the right femoral vein and the patient went to the intensive care unit (icu).The case was completed with cryo.No further patient complications have been reported as a result of this event.Additional information was received reporting the patient died the following day.The physician indicated that the patient experienced pulmonary edema,.

• Brand Name: ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 16514068
• MDR Text Key: 310987500
• Report Number: 2649622-2023-06101
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 00763000341503
• UDI-Public: 00763000341503
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2023
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 06636
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2023
• Date Device Manufactured: 10/24/2022
• 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: 4FC12 SHEATH & 99063-20 MAPPING CATHETER
• Patient Outcome(s): Required Intervention; Hospitalization; Death; Life Threatening
• Patient Age: 76 YR
• Patient Sex: Male