MAUDE Adverse Event Report: MEDTRONIC DLP

Model Number 24009

Device Problem Flushing Problem (1252)

Patient Problems Aortic Dissection (2491); Patient Problem/Medical Problem (2688)

Event Date 11/17/2015

Event Type  Injury  

Event Description

Pressure line side of the aortic root cannula (medtronic dlp) was not patient.It had to be removed during cardiac bypass surgery, when operating team realized it was not flushing and was replaced with a second one, causing latrogenic ascending aorta dissection due to a second hole.This caused an additional several hours of surgery due to removal of a large section of ascending aorta and additional blood products.

• Brand Name: DLP
• Type of Device: DLP
• Manufacturer (Section D): MEDTRONIC; minneapolis MN 55432
• MDR Report Key: 5260459
• MDR Text Key: 32580156
• Report Number: MW5058199
• 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: 11/25/2015

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: 24009
• Device Lot Number: 2015080817
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/25/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 77