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 Leak/Splash (1354); Gas/Air Leak (2946); Material Integrity Problem (2978); Protective Measures Problem (3015)

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

Event Date 01/30/2024

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, a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection; a system notice was received indicating that the safety system detected blood in the catheter handle, the injection was stopped and the vacuum disabled; a system notice was received indicating that there is a problem with the system and a system notice was received indicating that the refrigerant delivery path was obstructed.The electrical umbilical cable and coaxial umbilical cable were reconnected without resolve.The console was then restarted without resolve.The balloon catheter was removed from the patient and found to be ruptured.As a result a slight amount of gas entered the patient.The balloon catheter was replaced to resolve the issue. the case was completed with cryo. no patient complications have been reported as a result of this event.

Event Description

It was reported that during a cryo ablation procedure, a system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection; a system notice was received indicating that the safety system detected blood in the catheter handle, the injection was stopped and the vacuum disabled; a system notice was received indicating that there is a problem with the system and a system notice was received indicating that the refrigerant delivery path was obstructed.The electrical umbilical cable and coaxial umbilical cable were reconnected without resolve.The console was then restarted without resolve.The balloon catheter was removed from the patient and found to be ruptured.As a result a slight amount of gas entered the patient.The balloon catheter was replaced to resolve the issue. the case was completed with cryo. no patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data file and 2af283 balloon catheter with lot number 18778 were returned and analyzed.Power up test file and failure file were not received.The patient file was created the reported date of the event.Patient file is: empty.The returned device identification matches the reported complaint product identification.External visual inspection of the balloon segment showed blood/fluid inside the balloon.The catheter smart chip data was downloaded and reviewed.Data indicated the catheter was used for three 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 inspection and pressure testing of the shaft segment, a guidewire lumen breach was observed at the catheter tip.During inspection of the handle segment, blood / liquid was observed inside handle.During inspection and pressure testing of the handle segment, a leak path was identified at the vacuum tube to rear strain relief.The vacuum tube was partially detached from the strain relief.In conclusion, the reported issues were confirmed through testing.The balloon catheter failed the returned product inspection due to the breach on the guidewire lumen on the attachment to the tip and the bond leak at the vacuum tube to the rear strain relief fitting.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: 18631088
• MDR Text Key: 334760750
• Report Number: 3002648230-2024-00033
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P100010
• 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: 03/05/2024

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 Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 18778
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/02/2022
• 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 Age: 75 YR
• Patient Sex: Male
• Patient Weight: 70 KG