MAUDE Adverse Event Report: PERFUSION SYSTEMS BIO MEDICUS; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	30155
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that prior to use, at inventory check of a dlp high flow coronary artery ostial cannula, it was reported that the plastic-metal bond at the tip was twirled.The use of the device was unspecified.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the tip was not obstructed.The tip did not detach from the cannula body.The cannula was not heated or cooled prior to use.
Additional Manufacturer Narrative
Section e initial reporter: the first and last names and phone number of the initial report are not available due to regional privacy laws.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.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection showed the device was not used and the tip could be rotated.The reason for return was confirmed.Correction b5: medtronic received information that prior to use, at inventory check of the dlp high flow coronary artery ostial cannulae, it was reported that the plastic-metal bond at the tips were twirled.The devices were not used.Medtronic received additional information that the tips were not obstructed.The tips did not detach from the cannulae bodies.The c annulae were not heated or cooled prior to use.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.
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: BIO MEDICUS
• 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: 21503970
• Report Number: 2184009-2025-00381
• Device Sequence Number: 7901938
• Product Code: DWF
• UDI-Device Identifier: 00613994575968
• UDI-Public: (01)00613994575968(17)270410(10)2024040407
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup,Followup
• Report Date (Section B): 06/30/2025

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: 30155
• Device Catalogue Number: 30155
• Device Lot Number: 2024040407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 03/12/2025; 06/20/2025
• Initial Report FDA Received Date: 03/03/2025
• Supplement Report FDA Received Date: 04/04/2025; 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/10/2024
• 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 Sex: Unknown