MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP PERICARDIAL/INTRACARDIAC SUMPS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	12112
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	12/29/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Device evaluation summary: visual inspection showed no outward signs of any damage or sharp edges that would cause any issues.The reason for the return was not confirmed.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 during use of a dlp pericardial/intracardiac sump, it was reported that it had a problem.The device was replaced during the procedure.The patient passed away.Medtronic received additional information that the surgeon stated that during use they noticed that the device had touched the lateral wall of the left ventricle, with the risk of perforation.There was an impact to the patient as a second surgery was performed to repair the lesion in the patient.Medtronic received additional information that the patient is now deceased following repeated surgeries.A perforation of the lateral wall was confirmed.Medtronic received additional information that the exact cause of death was not identified.The patient's death was not believed to be linked to the performance of the dlp pericardial/intracardiac sump.

• Brand Name: DLP PERICARDIAL/INTRACARDIAC SUMPS
• 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: 24301875
• Report Number: 2184009-2026-00223
• Device Sequence Number: 5142722
• Product Code: DWF
• UDI-Device Identifier: 00613994619273
• UDI-Public: (01)00613994619273(17)280921(10)0232234251
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K850385
• 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): 02/10/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 12112
• Device Catalogue Number: 12112
• Device Lot Number: 0232234251
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Initial Report FDA Received Date: 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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
• Outcome Attributed to Adverse Event: Death; Required Intervention
• Patient Sex: Unknown