MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC; ARTERIAL CANNULA

Model Number 78320

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Stroke/CVA (1770)

Event Date 03/26/2015

Event Type  malfunction  

Event Description

Product: eopa 3d 20 fr arterial cannula from medtronic ref # (b)(4).The silastic ring that hooks into the medtronic straight aortic cannula was not found upon removal from the pt's chest and was suspected have intruded into the ascending aorta.The device did not malfunction; this piece is not attached by design.Surgeon notified mfr and was told this piece was radio-opaque.Xrays and ct's taken and it was not located.Pt did have a cva but it is unk if it is related to this event, as she was high risk.

• Brand Name: MEDTRONIC
• Type of Device: ARTERIAL CANNULA
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 4730543
• MDR Text Key: 5581146
• Report Number: MW5042308
• Device Sequence Number: 1
• Product Code: DWF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/17/2015

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
• Device Operator: Health Professional
• Device Model Number: 78320
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/17/2015
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Age: 83 YR