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

Model Number	AFAPRO28
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abdominal Pain (1685); Nausea (1970); Pleural Effusion (2010); Pulmonary Edema (2020); Tachycardia (2095); Sleep Dysfunction (2517); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/08/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was reported that post-operatively to a cryo ablation procedure, a chest x-ray showed pleural effusions with pulmonary venous congestion.Ten months later the patient arrived to the hospital with abdominal pain and nausea.The patient also reported difficulty sleeping.A blood test showed the patient's brain natriuretic peptide (bnp) and troponin levels were elevated.A chest x-ray was performed and showed bilateral pleural effusions again with pulmonary vein congestion as well as cardiomegaly.An abdomen and pelvis computed tomography angiography (cta) were performed and showed no acute process but diverticulosis and bilateral pleural effusions with infiltrative opacities in the lung.A loop diuretic was administered intravenously.An echocardiogram was performed and showed a mildly reduced left ventricle ejection fraction and indeterminant diastolic dysfunction.An electrocardiogram was performed and showed abnormal results.Another blood test was performed and showed slightly alkaline potential of hydrogen levels and a low red blood cell count.The patient was hospitalized for one day.A potassium supplement was administered orally and the patient's home loop diuretic dose was increased. the patient is a participant in a clinical study. no further patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Event or Problem Description
It was later reported that, three weeks post-operatively, the first x-ray was performed and showed small right pleural effusion with right basilar atelectasis.The patient was started on a loop diuretic, that was later increased in dosage, and the patient did not experience a worsening of symptoms.When the patient arrived to the hospital ten months later for the previously reported symptoms, an electrocardiogram (ecg) was performed and supra ventricular tachycardia (svt) was found.The svt was treated with cardioversion and a calcium-channel blocker, and recovered the following day.

• Brand Name: ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER
• Common Device Name: 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: 19089011
• Report Number: 2649622-2024-10055
• Device Sequence Number: 12530577
• Product Code: OAE
• UDI-Device Identifier: 00763000341503
• UDI-Public: 00763000341503
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P100010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 07694
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 04/11/2024
• Supplement Report FDA Received Date: 06/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/31/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female
• Patient Weight: 85 KG