MAUDE Adverse Event Report: MEDTRONIC, INC. CRYOCONSOLE; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	106A3
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Continuation of d10: product id afapro28 (lot: 26392); product type: 0624-arctic front catheter.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.
Event or Problem Description
It was reported that during a cardiac ablation procedure using the catheter afapro28 afa pro 28, after the cryoballoon catheter was connected to the console and all self-safety tests and flushing procedures were completed, balloon inflation and left superior pulmonary vein occlusion were achieved on the first attempt.During the first cryoablation attempt, the temperature failed to drop below -20 degrees celsius, and a system notice indicated that the refrigerant delivery path was obstructed.The cryoablation was terminated before reaching the one-minute mark.The vacuum was released and reactivated to enable a new system check and flushing procedure.Multiple attempts at cryoablation were made, and the cryoballoon catheter, coaxial umbilical, and electrical cables were replaced.A full console reset was performed, but the same error pattern persisted.The procedure was aborted under general anesthesia.No patient complications have been reported as a result of this event.

• Brand Name: CRYOCONSOLE
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23829557
• Report Number: 2182208-2025-13183
• Device Sequence Number: 18381247
• Product Code: LPB
• UDI-Device Identifier: 00763000011147
• UDI-Public: (01)00763000011147(11)210501
• Combination Product (Y/N): N
• Initial Reporter Country: HO
• PMA/510(K) Number: P020045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 106A3
• Device Catalogue Number: 106A3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2025
• Initial Report FDA Received Date: 12/17/2025
• Date Device Manufactured: 05/01/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 68 YR
• Patient Sex: Female