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)

Event Date 03/08/2024

Event Type  Injury  

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 Description

It was reported that during a cryo ablation procedure, the patient had profound hypotension after the last ablation.The case was completed with cryo.No effusion was observed on intracardiac echocardiography (ice).It was then reported that a pulse was not detected, requiring cardiopulmonary resuscitation to be performed on the patient.During compressions, a pulse returned and the patient stabilized.A transthoracic echocardiogram was then performed and again, no effusion was observed.The patient was intubated and monitored for a period of time with labile blood pressures.A chest computerized tomography (ct) scan was performed and the results were negative.The patient remained intubated in the intensive care unit (icu) until the following day, and was discharged without any deficit two days later.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation of d10: product id: 4fc12 product type: sheath; product id: 900304 product type: integrated dilator/needle product event summary: the data files were returned and analyzed.One patient file was received and recorded on the reported date of the event.The patient file showed 12 applications were performed using a catheter identified as afapro28 of lot 12960.The patient file did not show any system notice on the reported date of the event.The reported hypotension and cardiac arrest could issue could not be assessed through data analysis.The issue is not recorded to the data files.The console output data (pressure, preset pressure, and flow) did not show any temperature artifact.Pressure is tracking preset pressure and flow readings were as expected.The failure file has not been received.In conclusion, the reported hypotension and cardiac arrest could issue could not be assessed through data analysis.The balloon catheter was discarded and was not returned for analysis.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.

• 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: 18954626
• MDR Text Key: 338301948
• Report Number: 2649622-2024-07842
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 00763000707781
• UDI-Public: 00763000707781
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100010
• 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,Followup
• Report Date: 04/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• 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: 12960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/30/2023
• 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: SEE H11
• Patient Outcome(s): Required Intervention; Life Threatening; Hospitalization
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Weight: 109 KG