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 Problems Leak/Splash (1354); Mechanical Problem (1384); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015); Insufficient Information (3190)

Patient Problems Air Embolism (1697); Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095)

Event Date 05/02/2022

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure, air bubbles were observed on the intracardiac echocardiogram and fluoroscopy to be emitting from the balloon while freezing.The patient became hypotensive and went into a cardiac ventricular standstill/pulseless electrical activity(pea).The patient was given intravenous (iv) epinephrine medication for the pea.The patient was then tachycardic with cardiac movement.The patient recovered immediately, was hemodynamically stable, and no neurological deficits were noted.Blood was observed in the coaxial umbilical cable.The console was turned off and the coax was disconnected from the console.When the console was turned on, a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection.When the balloon catheter was suspected to be ruptured and leaking, it was removed from the body, both balloons appeared to be intact, and questionable confirmation for an inner lumen fracture at the proximal end of the balloon.The balloon catheter was replaced. the case was completed with cryo.Following the case, the data files were unable to be downloaded for the case.Test injections were performed and the data files from the test injections showed the pressure was not as expected. no further patient complications have been reported as a result of this event.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product event summary: the data files and afapro28 balloon catheter with lot 15561 were returned analyzed.The data files showed that at least 18 applications were performed with the returned catheter on the event date.The data files showed that the system notices #50005 (a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection) and #50006 (the safety system has detected blood in the cath handle, stopped the injection and disabled the vacuum) were triggered multiple times on the event date.External visual inspection of the balloon segment showed blood/fluid inside the balloon.During functional testing, the console terminated the application and triggered system notice #50005.Pressure testing and inspection of the sub-components of the balloon, handle, and shaft segments were performed.The traces of blood inside the handle were observed.During inspection and pressure testing of the shaft segment, a guide wire lumen kink and breach were observed 0.728 inches proximal to the catheter tip.In conclusion, the reported guide wire lumen kink and breach were confirmed through testing.The clinical issues (cardiac arrest, arrhythmia, hypotension, air embolism) occurred during the procedure.There is no indication of a relation of the adverse event to the performance and malfunction of the product.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.

• 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: 14410127
• MDR Text Key: 291745746
• Report Number: 2649622-2022-09354
• 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,Followup
• Report Date: 06/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2023
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 03834
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/02/2022
• 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
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 71 YR
• Patient Sex: Male