MAUDE Adverse Event Report: PERFUSION SYSTEMS CANNULA 77208 ART ONE PIECE 8FR; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	77208
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Medtronic received information that during use of a dlp pediatric one-piece arterial cannula, it was reported that the cannula sheath was broken.The reinforcing wire was visible.The device was replaced to complete the procedure.There was no adverse patient effect associated with this event.Medtronic received additional information from the customer stating that there was no leak at the cannula body.The customer stated that the issue happened when the cannula was drawn out.Information on whether the cannula was heated or cooled prior to use was not available, but the customer stated that this is not normally their practice.The customer stated that the cause of the damage was unknown.Medtronic received additional information that the cannula was damaged in the front part of the cannula body.The cannula body was broken when the cannula was taken out of the aorta.Before introducing it, there was no damage seen.The performance and flow during the procedure were as expected.The customer could not confirm if the cannula was sutured.
Additional Manufacturer Narrative
Device evaluation summary: visual inspection showed evidence of damage to the outer sheath at the tip of the device.The 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.
Additional Manufacturer Narrative
Additional info h6: updated the fdc/ annex d code 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: CANNULA 77208 ART ONE PIECE 8FR
• 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: 19077776
• Report Number: 2184009-2024-00171
• Device Sequence Number: 20401206
• Product Code: DWF
• UDI-Device Identifier: 00763000091033
• UDI-Public: 00763000091033
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/30/2024

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: 06/28/2026
• Device Model Number: 77208
• Device Catalogue Number: 77208
• Device Lot Number: 2023061622
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/10/2024
• Supplement Report FDA Received Date: 10/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2023
• 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 Sex: Unknown