MAUDE Adverse Event Report: ORIGEN BIOMEDICAL ORIGEN VV 19FR CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number VV 19FR

Device Problem Off-Label Use (1494)

Patient Problem No Information (3190)

Event Date 11/25/2017

Event Type  malfunction  

Event Description

The vv 19fr cannula was used to place pt on ecmo.It was determined, after placement, that it was not radio opaque and the ability to identify proper placement after insertion was compromised, because it was not visible on xray.Diagnosis or reason for use: vv ecmo support.

• Brand Name: ORIGEN VV 19FR CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): ORIGEN BIOMEDICAL; 7000 burleson road, blvd d; austin TX 78744
• MDR Report Key: 7084013
• MDR Text Key: 93825888
• Report Number: MW5073744
• Device Sequence Number: 0
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2019
• Device Model Number: VV 19FR
• Device Lot Number: P18971
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/04/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 15 MO