MAUDE Adverse Event Report: PERFUSION SYSTEMS EOPA 3D VENTED ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number	78222
Medical Device Problem Code	Device Slipped (1584)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medtronic is unable to determine the root cause of the issue at the current time without the return of the product.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during the removal of this eopa arterial cannula the suture collar stayed trapped in the aortic intravascular.The suture collar then migrated to the aortoiliac junction.The suture collar was extracted via endovascular surgery.It is unknown whether the customer continued to use the cannula after experiencing this issue.There were no other adverse patient effects.

• Brand Name: EOPA 3D VENTED ARTERIAL CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 7366043
• Report Number: 2184009-2018-00010
• Device Sequence Number: 13947279
• Product Code: DWF
• UDI-Device Identifier: 20643169486250
• UDI-Public: 20643169486250
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K150422
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: 78222
• Device Catalogue Number: 78222
• Device Lot Number: 2017081682
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2018
• Initial Report FDA Received Date: 03/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention