MAUDE Adverse Event Report: MEDTRONIC PERFUSION SYSTEMS ELECTRICAL UMBILICAL CABLE

Model Number	2035U
Medical Device Problem Codes	Off-Label Use (1494); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the electrical cable for the cardiac ablation catheter was connected, the system did not recognize the catheter and a system notice appeared indicating an unrecognized catheter.Attempts to disconnect and reconnect the cable did not resolve the issue, so the electrical cable was replaced, which resolved the problem.The case was completed with cryo.It was later noted that the electrical umbilical cable was used past its use by date and was expired.No patient complications have been reported as a result of this event.
Additional 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.

• Brand Name: ELECTRICAL UMBILICAL CABLE
• Common Device Name: CABLE
• Manufacturer (Section D): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr; minneapolis,mn
• Manufacturer (Section G): MEDTRONIC PERFUSION SYSTEMS; 7611 northland dr; minneapolis,mn
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 23579697
• Report Number: 2182208-2025-09748
• Device Sequence Number: 13137899
• Product Code: ISN
• UDI-Device Identifier: 00763000359355
• UDI-Public: (01)00763000359355(17)250918(10)G23A09359
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/18/2025

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: 09/18/2025
• Device Model Number: 2035U
• Device Catalogue Number: 2035U
• Device Lot Number: G23A09359
• 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: 11/10/2025
• Initial Report FDA Received Date: 11/18/2025
• Date Device Manufactured: 09/18/2023
• 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
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 65 KG