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 Device Contamination with Body Fluid (2317); Material Integrity Problem (2978); Protective Measures Problem (3015)

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

Event Date 03/05/2024

Event Type  malfunction  

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.The balloon catheter was reconnected to resolve the issue.A system notice was received indicating that there was a problem with the injection process.The coaxial umbilical cable was replaced which resolved the issue.When all the therapy was finished but while the balloon catheter was still in the body, a system notice was received indicating that the safety system detected blood in the catheter handle, the injection was stopped and the vacuum disabled.The system notices were attempted to be 'clicked' through then the coaxial umbilical cable and balloon catheter were disconnected from the console.Blood was observed at the coaxial connection. the case was completed with cryo. no patient complications have been reported as a result of this event.

Manufacturer Narrative

Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Product event summary: the data files, image files, and afapro28 balloon catheter with lot number 15678 were returned and analyzed.The patient data file showed 14 applications were performed using the afapro28 balloon catheter with lot number 15678.The patient date file showed system notice 50028 (there is a problem with the injection process) during during inflation of application eight.The received failure file contained failure records for the date of the event and showed persistent system notice 50005 (the safety system has detected fluid in the catheter and stopped the injection), persistent system notice 50006 (the safety system has detected blood in the catheter handle stopped the injection and disabled the vacuum), and system notice 50028 (there is a problem with the injection process) on the reported date of the event.The first image showed blood inside a console coaxial port and the second image showed a console blood bottle with no blood inside.External visual inspection of the balloon catheter's balloon segment showed blood/fluid inside the balloon.The catheter smart chip data was downloaded and reviewed.Data indicated the catheter was used for 16 applications on the reported event date.During functional testing, the console terminated the application and triggered system notice 50005.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 reported visual blood issue and system notices (50005, 50006, 50028) was confirmed and the balloon catheter failed the returned product inspection due to a double balloon breach.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• 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 ; EI ; 091708096
• MDR Report Key: 18952340
• MDR Text Key: 339154204
• Report Number: 3002648230-2024-00103
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 15678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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.