MAUDE Adverse Event Report: MPRI ARCTIC FRONT ADVANCE PRO¿ CARDIAC CRYOABLATION CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number	AFAPRO28
Medical Device Problem Codes	Device Contamination with Body Fluid (2317); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure involving the  sheath and the cryoballoon catheter, there were multiple issues.The scrub tech experienced difficulty snapping the dilator into the hub of the sheath,.Despite following the correct protocol, the dilator would not secure, and due to a shortage of sheaths, it was not replaced.The physician opted to manually hold the dilator in place to proceed with the procedure.During the case, after ablating the left pulmonary veins, a system notice was received indicating the safety system detected blood in the catheter handle, prompting the cessation of injection and disabling of the vacuum.Blood was observed flowing back through the balloon catheter and into the coaxial umbilical, but it was partially contained before the coaxial umbilical was detached from the cryo console, preventing any blood from entering the console.The field contact instructed the physician to remove the cryo balloon catheter from the body under fluoroscopic guidance.Both the catheter and the coaxial umbilical were replaced, allowing the procedure to continue without further issues. no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
Continuation of d10: product id 4fc12 (lot: 0012154449); product type: 0629-flexcath sheath; implant date n/a; explant date n/a product id 106a3 (serial: (b)(6)); product type: 0628-console & spare parts; implant date n/a; explant date n/a 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.
Additional Manufacturer Narrative
Product event summary: the patient data files were returned and analyzed.The patient file was created on the reported date of the e vent, and the text format was not valid and/or could not be assessed.The received failure file contained failure records for the date of the event.The failure file showed system notice 50006 (the safety system has detected blood in the catheter handle stopped the injection and disabled the vacuum) on the reported date of the event.In conclusion, the reported issue of visible blood was unable to be confirmed through device data analysis; however, a system notice 50006 was identified in the data files.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.
Additional Manufacturer Narrative
Product event summary: the afapro28 balloon catheter with lot number 20394 was returned and analyzed.Visual inspection of the balloon showed blood inside the balloon.Review of the smart chip data indicated the catheter was used for 11 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).Pressure testing and dissection of the balloon segment revealed an outer balloon breach (pinhole type).In conclusion, the reported visible blood was observed during testing and the balloon catheter did not pass returned product inspection due to a pin size hole on the surface of the outer balloon.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
• Common Device Name: 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: 20892511
• Report Number: 2649622-2024-33254
• Device Sequence Number: 7772688
• Product Code: OAE
• UDI-Device Identifier: 00763000707781
• UDI-Public: 00763000707781
• Combination Product (Y/N): N
• Initial Reporter State: DC
• Initial Reporter Country: US
• PMA/510(K) Number: P100010
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/06/2025
• Device Model Number: AFAPRO28
• Device Catalogue Number: AFAPRO28
• Device Lot Number: 20394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 12/17/2024; 01/10/2025
• Initial Report FDA Received Date: 12/10/2024
• Supplement Report FDA Received Date: 01/08/2025; 02/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11...
• Patient Age: 56 YR
• Patient Sex: Male