MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE® CARDIAC CRYOABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number 2AF283

Device Problems Mechanical Problem (1384); Device Contamination with Body Fluid (2317); Protective Measures Problem (3015)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/24/2023

Event Type  malfunction  

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 during a cryo ablation procedure, there was in the coaxial connection and the inner balloon ruptured.The balloon catheter was replaced which resolved the issue. the case was completed with cryo. no patient complications have been reported as a result of this event.

Event Description

There was blood return in the coaxial tube.

Manufacturer Narrative

Correction: event description product event summary: the 2af283 balloon catheter with lot number 15631 and data files were returned and analyzed.External visual inspection of the balloon segment showed blood/fluid inside the balloon.The catheter smart chip data was reviewed.Data indicated the catheter was never used.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." pressurizing of the outer balloon identified the outer balloon distal bond was leaking and detached from the shaft.Dissection of the outer-balloon segment and pressurizing the inner balloon identified the inner balloon distal bond was leaking and detached from the shaft.The patient file showed nine applications were performed using a balloon catheter identified as 2af283 with lot 18723.The patient file didn't show any system notice on the reported date of the event.In conclusion, the reported visible blood and 'rupture' issue were confirmed through analysis and the balloon catheter failed the returned product inspection due to a an outer balloon distal bond detachment and inner balloon distal bond detachment.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® 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 ; EI ; 091708096
• MDR Report Key: 17721279
• MDR Text Key: 323097660
• Report Number: 3002648230-2023-00420
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2024
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 15631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 09/19/2023
• Supplement Dates FDA Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2022
• 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
• Treatment: 203CX COAXIAL UMBILICAL CABLE
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 95 KG