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

Model Number	30112
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use of the dlp high flow coronary artery ostial cannulae, it was reported that the hospital warehouse checked all the products in the hospital and many of the devices had a loose suction tip, but the rest did not.There was no patient involvement, so no adverse effect occurred.The customer stated that if the suction tip was loose, it might cause the tip end to fall off during use, causing unnecessary trouble.Medtronic received additional information that for the devices returned in the sealed pouches, it was determined that some of these devices had loose tips as the customer turned the tip through the bag and observed that they were loose.The complained products were all defective and had been checked.They were checked by turning the tip through the bag.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection of the device shows no outward signs of any damage.The tip was loose on the device.This regulatory report is being submitted due to retrospective review through capa 624392.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: DLP HIGH FLOW CORONARY ARTERY 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: 21372570
• Report Number: 2184009-2025-00142
• Device Sequence Number: 12917770
• Product Code: DWF
• UDI-Device Identifier: 00613994575982
• UDI-Public: 00613994575982
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2025

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: 02/22/2026
• Device Model Number: 30112
• Device Catalogue Number: 30112
• Device Lot Number: 2023021190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2023
• Initial Report FDA Received Date: 02/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/22/2023
• 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 Sex: Unknown