MAUDE Adverse Event Report: MEDTRONIC, INC. AORTIC ROOT CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 12/18/2017

Event Type  malfunction  

Event Description

Aortic root vent device was discovered to be defective prior to start of a case.Packaging material was discarded, therefore no device information is available.The cannula came apart where it is supposed to stay attached to the hub.Device to be given to medline rep.For further review.

Manufacturer Narrative

The following elements have blank data: device manufacturer's street address: (line 1) for type of device: catheter, cannula and tubing, vascular, cardiopulmonary bypass.City: for type of device: catheter, cannula and tubing, vascular, cardiopulmonary bypass.State: for type of device: catheter, cannula and tubing, vascular, cardiopulmonary bypass.Zip: for type of device: catheter, cannula and tubing, vascular, cardiopulmonary bypass.

Event Description

Aortic root vent device was discovered to be defective prior to start of a case.Packaging material was discarded, therefore no device information is available.The cannula came apart where it is supposed to stay attached to the hub.Device to be given to medline rep.For further review.

• Brand Name: AORTIC ROOT CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7164374
• MDR Text Key: 96398699
• Report Number: 7164374
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

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: No Information
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/20/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/20/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1