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 Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513)

Event Date 08/07/2023

Event Type  Injury  

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 post-operatively to a cryoablation procedure, the patient experienced a drop in blood pressure that required treatment. no further patient complications have been reported as a result of this event.

Event Description

It was later reported that the patient's blood pressure dropped while another manufacturer's radiofrequency (rf) catheter was being used in the patient's superior vena cava (svc).It was also reported that the patient experienced a perforation.The injuries were treated with a pericardiocentesis and tap.The patient was subsequently hospitalized.Plausible:health professional: known inherent risk of device known inherent risk of device adverse event without identified device or use problem type of investigation not yet determined hypotension cardiac perforation results pending completion of investigation low blood pressure/ hypotension cardiac perforation life threatening illness or injury hospitalization or prolonged hospitalization unexpected medical intervention part/component/sub-assembly term not applicable hypotension perforation of venous or cardiac or surrounding tissue.

Manufacturer Narrative

Continuation of d10: product id: 4fc12, product type: sheath; product id: 990063-015, product type: mapping catheter.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

Continuation of d10: product id: unknown product type: radiofrequency (rf) catheter.Product event summary: the data file was returned and analyzed.The patient data files showed at least nine applications were performed with afapro28 balloon catheter with lot number 09908 without any issue on the date of the event.In conclusion, the reported clinical issue (perforation and hypotension) occurred during the procedure.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.

• 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 MN 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba,pr MN 00766
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17756919
• MDR Text Key: 323519486
• Report Number: 2182208-2023-02655
• 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: Other,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2023

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
• Device Operator: Health Professional
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 09908
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 09/29/2023; 10/25/2023
• Supplement Dates FDA Received: 10/16/2023; 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2023
• 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 H10...; SEE H10...
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 93 KG