MAUDE Adverse Event Report: PERFUSION SYSTEMS CANNULA 77010 ART ONE PIECE 10FR; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	77010
Medical Device Problem Codes	Obstruction of Flow (2423); Misassembled During Installation (4049)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
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 at an unspecified time, this dlp pediatric one-piece arterial cannula had a cap of the introducer that was fitted backwards; hence, it does not occlude the cannula.No patient was hurt, as the defect was noticed timely.The use of the device was unspecified.There was no adverse patient effect reported with this event.
Additional Manufacturer Narrative
Correction b5: additional review of this event showed that it was a misassembly issue prior to use, not a flow issue.Additional review of the event and additional information received shows that there is no information to reasonably suggest that the device in this report may have caused or contributed to a death or serious injury or that the device in this report has malfunctioned.Therefore, this event did not and does not meet the reporting requirements in 21 cfr 803.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 dlp pediatric one-piece arterial cannula, it was reported that the cap of the introducer was fitted backwards, hence, it does not occlude the cannula.No patient was hurt, as the the defect was noticed timely.The device was replaced.There was no patient involvement, so no adverse effect occurred.Medtronic received additional information that the issue was observed when seeing the cannula in the packaging.

• Brand Name: CANNULA 77010 ART ONE PIECE 10FR
• 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: 20046007
• Report Number: 2184009-2024-00498
• Device Sequence Number: 7933441
• Product Code: DWF
• UDI-Device Identifier: 00763000091118
• UDI-Public: 00763000091118
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: K024069
• 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
• Report Date (Section B): 08/30/2024

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: 08/23/2026
• Device Model Number: 77010
• Device Catalogue Number: 77010
• Device Lot Number: 2023081305
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2024
• Supplement Date Received by Manufacturer: 08/23/2024
• Initial Report FDA Received Date: 08/23/2024
• Supplement Report FDA Received Date: 08/30/2024
• Date Device Manufactured: 08/23/2023
• 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 Sex: Unknown