MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP LEFT HEART VENT CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	12113
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use of a dlp left heart vent catheter, it was reported that the metal in the product seems different.It is thicker and stiffer than before and does not hold its shape.The device was replaced.There was no patient involvement, so no adverse effect occurred.The customer is asking if the wire was changed or something was changed in the design.There are pictures comparing it to the 15 french and the wire looks way bigger in the 13 french against the old 15 french.Unopened packages will be returned for analysis.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows no outward signs of any damage.Device will be sent to the vendor for additional analysis.Reason for return was undetermined.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 LEFT HEART VENT CATHETER
• 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: 23001568
• Report Number: 2184009-2025-01105
• Device Sequence Number: 9089610
• Product Code: DWF
• UDI-Device Identifier: 00643169881334
• UDI-Public: (01)00643169881334(17)260614(10)2023060762
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K834039
• 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): 09/09/2025

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: 06/14/2026
• Device Model Number: 12113
• Device Catalogue Number: 12113
• Device Lot Number: 2023060762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 09/09/2025
• Date Device Manufactured: 06/14/2023
• 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