MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION AORTIC ROOT CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Lot Number 17GK0042

Device Problems Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2017

Event Type  malfunction  

Event Description

During open heart procedure, the surgeon placed the root vent into the root of the aorta to vent it and to provide cardioplegia to the heart.Shortly after placing the root vent and attaching it to the perfusion lines, while giving cardioplegia, the connection on the root vent side dislodged from the rest of the root vent.The surgeon was able to clamp and reattach the root vent to the line and clamp into place.The device separated and did not hold the seal.No patient harm.

• Brand Name: AORTIC ROOT CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 east deere ave.; santa ana CA 92705
• MDR Report Key: 7009339
• MDR Text Key: 91358797
• Report Number: 7009339
• 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
• Report Date: 10/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 17GK0042
• Other Device ID Number: DYNJ56421
• 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: 10/11/2017
• Event Location: Other
• Date Report to Manufacturer: 10/11/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR