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 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 03/20/2024

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 a compromised outer vacuum.Another system notice was received indicating that the safety system detected fluid in the catheter and stopped the injection.It was then reported that blood was coming back into the balloon catheter handle and slightly into the coaxial umbilical cable.The coaxial umbilical cable was promptly disconnected from the console.The balloon catheter was replaced which resolved the issue.The coaxial umbilical cable was also replaced and the case was completed with cryo.Data files are unavailable due to a power failure.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Continuation of d10: product id: 203cx, product type: coaxial umbilical cable.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 afapro28 balloon catheter with lot number 17536 was returned and analyzed.Visual inspection of the balloon, shaft, and handle segments was carries out and visual inspection of the balloon segment showed a leak path from the outer balloon.The outer balloon proximal bond was partially detached from the catheter shaft.Visual inspection of the balloon segment showed blood inside the balloon.Visual inspection of the shaft segment showed a fold/pinch approximately three inches from the tip.The catheter smart chip data was downloaded and reviewed.Data indicated the catheter was used for 18 applications on the reported event date.During functional testing, the console terminated the application and triggered system notice #50005 indicating that the safety system detected fluid in the catheter and stopped the injection.Pressure testing and inspection of sub-components of the balloon, handle, and shaft segments was carried out.Pressurizing of the outer balloon identified the outer balloon proximal bond was leaking and detached from the shaft.During inspection of the shaft segment, a guide wire lumen kink/twist was observed 1.25 inches proximal to the catheter tip.Pressure testing did not identify any leakage from the kink.During inspection of the shaft segment, a leak detection wire excessive length was observed inside shaft.During inspection of the handle segment, blood was observed inside handle.In conclusion, the reported visible blood and the system notice #50005 was confirmed and the returned balloon catheter failed the returned product inspection due to a bond detachment at the outer balloon proximal bond, a kink/twist on the guide wire lumen.The shaft was folded and damaged and excessive length of tc/ld wires in the shaft segment was observed.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): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18990730
• MDR Text Key: 338786725
• Report Number: 2649622-2024-08426
• 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
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 17536
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/05/2024
• 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 H11...
• Patient Sex: Male