MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP LEFT HEART VENT CATHETER; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYP

Model Number	12116
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: device appears to have been cleaned.Visual inspection shows the malleable guidewire is protruding from the distal end of the cannula.Reason for return was confirmed.This report is being submitted as part of remediation activities associated with capa # 643143, which is addressing mdr reporting guidance from fdas 1995 preamble, which ensures complaints related to corrections and recalls which were previously reported to fda under 21 cfr 806 are now reported as mdrs; this is not a new malfunction/event.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
Medtronic received information that prior to use of a 12116 dlp left heart vent catheter, the customer reported that the wire of the cannula hits the tip of it and was protruding.The device was replaced.There was no patient involvement so no adverse effect occurred.

• Brand Name: DLP LEFT HEART VENT CATHETER
• Common Device Name: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYP
• 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: 22284629
• Report Number: 2184009-2025-00784
• Device Sequence Number: 18361826
• Product Code: DTS
• UDI-Device Identifier: 00643169086715
• UDI-Public: 00643169086715
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K834352
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/18/2025

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: 05/31/2023
• Device Model Number: 12116
• Device Catalogue Number: 12116
• Device Lot Number: 2020050699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2021
• Initial Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2020
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2505-2021
• Patient Sequence Number: 1
• Patient Sex: Unknown