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

Model Number 78222

Device Problem Device Slipped (1584)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/22/2018

Event Type  Injury  

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 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
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• 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: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 7366043
• MDR Text Key: 103322854
• Report Number: 2184009-2018-00010
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 20643169486250
• UDI-Public: 20643169486250
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K150422
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2018
• Initial Date FDA Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/12/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention