MAUDE Adverse Event Report: PERFUSION SYSTEMS CORONARY OSTIAL ANTEGRADE CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	30012
Medical Device Problem Codes	Fluid/Blood Leak (1250); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a dlp coronary artery ostial cannula, the customer reported a leak.The leak was between the metal handle and the blue plastic dispersion tip at the distal end of the device.Fluid was noted to be coming out around the junction of the tip connection and not just out of the end holes as it should have been.Patient blood loss did not occur as a result of this leak.An unplanned blood transfusion was not required.The device was replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information that there was an abnormal distribution of the spg solution.There was internal obstruction possible.The ostial cardioplegia was handheld.The original intended procedure was for an aortic root replacement with 27mm konnect graft, coronary artery bypass grafting and saphenous vein graft to distal right coronary artery (rca).
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: CORONARY OSTIAL ANTEGRADE CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 21106019
• Report Number: 2184009-2025-00016
• Device Sequence Number: 8782425
• Product Code: DWF
• UDI-Device Identifier: 00613994576033
• UDI-Public: 00613994576033
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K131269
• 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
• Report Date (Section B): 01/08/2025

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 Model Number: 30012
• Device Catalogue Number: 30012
• Device Lot Number: 2024040834
• 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: 12/13/2024
• Initial Report FDA Received Date: 01/08/2025
• Date Device Manufactured: 04/25/2024
• 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
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 69 KG
• Patient Race: White