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 Problems Material Deformation (2976); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 12/02/2021

Event Type  Injury  

Event Description

It was reported that during a cryoablation procedure, a system notice was received indicating that the safety system detected a compromised outer vacuum.Cables were replaced, but the issue persisted upon another ablation attempt.It was suspected that the balloon had ruptured.The patient then went into cardiac arrest when attempting to replace the balloon catheter.The patient was resuscitated successfully.The case was aborted while the patient was under general anesthesia.The patient was intubated, but stable upon moving from the operating room to the intensive care unit (icu).If was further reported that the patient was extubated and was fully recovered later that day.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 were returned and analyzed.The data files showed at least 10 applications were performed with afapro28 balloon catheter with lot 14543 on the date of the event.The data files showed system notice #50011 (the refrigerant delivery path is obstructed) in the beginning of the application 1 and system notice #50032 (the safety system has detected a compromised outer vacuum) at applications 8, 9 and 10.In conclusion, the clinical issue (cardiac arrest) occurred during the procedure.The case was aborted under general anesthesia there is no indication of relation of 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.

Manufacturer Narrative

Product event summary: the afaprao28 balloon catheter with lot was returned and analyzed.No anomalies were identified during external visual inspection of the balloon, shaft, and handle segments.The catheter smart chip data was downloaded and reviewed.Data indicated the catheter was used for 10 applications on the reported event date.During functional testing, the console terminated the application and triggered system notice #50005 (the safety system detected fluid in the catheter and stopped the injection).During pressure testing of the balloon segment, a double-balloon breach condition was identified.Dissection did not show any signs of lifted thermocouple wires or leak detection wires that could have caused the breach.In conclusion, the balloon catheter failed the returned product inspection due to a double balloon breach.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): 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, MN ; EI ; 7635055378
• MDR Report Key: 13043825
• MDR Text Key: 282501148
• Report Number: 3002648230-2021-00578
• Device Sequence Number: 1
• Product Code: OAE
• UDI-Device Identifier: 00763000245436
• UDI-Public: 00763000245436
• 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,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2022
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 14543
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2021
• 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): Hospitalization; Life Threatening; Required Intervention