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

Model Number	31002
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2024
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 i.M.A.Cannula, it was reported that the tip broke off the 2mm vessel cannula during vein harvesting during the coronary artery bypass graft (cabg) procedure.While checking the vein at the end of the back table, the customer noticed that the tip came off the 2mm vessel cannula and bounced off the table away from the operative field.This was immediately raised by the circulating team and the surgeon.The entire room was searched multiple times and after thoroughly searching the room, the broken piece was located by the perfusionist.For reference, the piece was no larger than a grain of rice.The customer stated that it was possibly due to a defective device as the tip should never come apart from the cannula.The use of the device was unspecified.There was no adverse patient effect associated with this event.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection shows a section of the tip is broken off.Reason for 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.
Event or Problem Description
Medtronic received information that during use of a dlp arteriotomy cannula, it was reported that the tip broke off the 2 mm vessel cannula during vein harvesting during the coronary artery bypass graft (cabg) procedure.While checking the vein at the end of the back table, the customer noticed that the tip came off the 2 mm vessel cannula and bounced off the table away from the operative field.This was immediately raised by the circulating team and the surgeon.The entire room was searched multiple times and after thoroughly searching the room, the broken piece was located by the perfusionist.For reference, the piece was no larger than a grain of rice.The customer stated that it was possibly due to a defective device as the tip should never come apart from the cannula.The use of the device was unspecified.There was no adverse patient effect associated with this event.
Additional Manufacturer Narrative
Correction b5: updated device name.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 ARTERIOTOMY CANNULA
• 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: 20199381
• Report Number: 2184009-2024-00535
• Device Sequence Number: 17811140
• Product Code: DWF
• UDI-Device Identifier: 00613994575333
• UDI-Public: 00613994575333
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K810820
• 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): 06/27/2025

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: 31002
• Device Catalogue Number: 31002
• Device Lot Number: 2023121315
• 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: 09/10/2024
• Supplement Date Received by Manufacturer: 10/29/2024; 06/26/2025
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 11/21/2024; 06/27/2025
• Date Device Manufactured: 12/28/2023
• 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 Age: 42 YR
• Patient Sex: Female