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 Material Integrity Problem (2978); Protective Measures Problem (3015); Device Handling Problem (3265)

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

Event Date 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

Continuation of d10: product id 203cx (lot: 226729687); product type: cables and accessories; product id 106a3 (serial: 5m0827); product type: console spare parts;  product id 990063-020 (lot: 227290639); product type: achieve catheter;  product id 203cx (lot: 227138401); product type: cables and accessories;  product id afapro28 (12013); product type: arctic front 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.

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 continue button was pressed without resolution.It was also reported that there was difficulty maneuvering/rewrapping the balloon catheter to another vein.The balloon catheter and coaxial umbilical cable were replaced, but then a system notice was received indicating that there was a problem with the refrigerant port.  vacuum was released and the balloon catheter and coaxial umbilical cable were disconnected and removed from the patient.When the mapping catheter was removed, the braiding appeared to be "mangled." blood was visible in the coaxial port and in the coaxial umbilical cable.The case was switched to and completed with radiofrequency (rf). no patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files and the afapro28 balloon catheter with lot number 12385 were returned and analyzed.One patient file was received and recorded on the day of the event.The patient file showed eight applications were performed using the balloon catheter afapro28 of lot number 12385.The patient file did not show any system notices on the reported event date.The received failure file contained failure records for the date of the event.Failure file showed persistent system notice 50005 (the safety system has detected fluid in the catheter and stopped the injection).External visual inspection of the balloon, shaft, and handle segments was carried out and blood/fluid was seen inside the balloon catheter.The catheter smart chip data was downloaded and reviewed.Data indicated the catheter was used for eight applications on the reported event date.During functional testing, the console terminated the application and triggered system notice 50005(the safety system has detected fluid in the catheter and stopped the inject ion.Deflection testing (lever pushed to the forward and backward position) was performed, the shaft reacted as initially intended.No kinks were identified on the shaft and after dissection, the pull wires were also intact.Pressure testing and inspection of sub -components of the balloon, handle, and shaft segments was carried out.During inspection and pressure testing of the shaft segment, a guide wire lumen breach was observed at the catheter tip.In conclusion, the reported visual blood issue and 50005 system notice were confirmed through analysis.The steerability issue was not confirmed through analysis.The balloon catheter failed the returned product inspection due to a guide wire lumen breach.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 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: 18278038
• MDR Text Key: 329931621
• Report Number: 2649622-2023-34645
• Device Sequence Number: 1
• Product Code: OAE
• 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: 01/05/2024

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: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 12385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/06/2023
• Supplement Dates Manufacturer Received: 12/07/2023
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2023
• 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...
• Patient Age: 88 YR
• Patient Sex: Female
• Patient Weight: 55 KG