MAUDE Adverse Event Report: MEDTRONIC GRAND RAPIDS DLP CORONARY ARTERY OSTIAL ANTEGRADE CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	30014
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2026
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Medtronic received information that during use of a dlp coronary artery ostial cannula, it was reported that the device was completely blocked and there was no flow at all through the cannula.The instrument was replaced to complete the procedure.There was no adverse patient effect associated with this event.
Additional Manufacturer Narrative
Correction b5.The device was replaced to complete the procedure.Additional information b5.Medtronic received additional information that there does not appear to be any damage to the product and the packaging was also intact.The event occurred during cardiopulmonary bypass (cpb) but when the issue was observed they swapped the product for an alternative.The issue did not worsen over time as there was no flow and the device was replaced immediately.No further issues afterwards and the case continued as normal.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
Correction b5: the device was replaced to complete the procedure.Correction section d3 (mfr name), d3.1 (street 1), d3.3 (mfr city), d3.4 (mfr region) and d3.6 (postal code): these fields have been updated.Device evaluation summary: visual inspection of the used device showed evidence of a blockage in the tip of the device.The device was connected to a syringe filled with deionized water and when it was engaged there was no flow.The reason for the return was 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.
Additional Manufacturer Narrative
Correction b5: medtronic received information that prior to use of a dlp coronary artery ostial cannula, it was reported that the device was completely blocked and there was no flow at all through the cannula.The device was replaced to complete the procedure.There was no patient involvement, so no adverse effect occurred.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.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: DLP CORONARY ARTERY OSTIAL ANTEGRADE CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): MEDTRONIC GRAND RAPIDS; 620 watson sw; grand rapids MI 49504
• Manufacturer (Section G): MEDTRONIC GRAND RAPIDS; 620 watson sw; grand rapids MI 49504
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 24211059
• Report Number: 2184009-2026-00181
• Device Sequence Number: 5431309
• Product Code: DWF
• UDI-Device Identifier: 00613994576026
• UDI-Public: (01)00613994576026(17)270710(10)2024070362
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/27/2026

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: 30014
• Device Catalogue Number: 30014
• Device Lot Number: 2024070362
• 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: 01/27/2026
• Supplement Date Received by Manufacturer: 01/30/2026; 03/04/2026; 04/23/2026
• Initial Report FDA Received Date: 01/29/2026
• Supplement Report FDA Received Date: 02/03/2026; 03/31/2026; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2024
• 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