MAUDE Adverse Event Report: ORIGEN BIOMEDICAL, INC ORIGEN DUAL LUMEN CATHETER; VV ECMO CATHETER

Model Number VV13F

Device Problems Infusion or Flow Problem (2964); Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

The catheter was returned to origen, where it was sterilized and examined.After inspecting the device as received, it was clear that there was a difference in color and the layers of the catheter separated.To manufacture the catheters, an inner extrusion is produced, wire is wrapped around the extrusion, and cinched down using a teflon shrink tube; the teflon shrink tube is then removed and a final outer layer of blue pebax is fused over the wire layer.The most likely root cause is that the teflon shrink tube was not fully removed on this catheter, and that a thin layer of the final pebax layer covered the teflon.It is likely that the blue outer layer must have covered the teflon layer so it was not visible during inspections, but this was not secure and became dislodged during use.This supplier is no longer in use for unrelated reasons.

Event Description

There is a weak spot in the vv13f catheter that is affecting flow.

• Brand Name: ORIGEN DUAL LUMEN CATHETER
• Type of Device: VV ECMO CATHETER
• Manufacturer (Section D): ORIGEN BIOMEDICAL, INC; 7000 burleson rd.; bldg. d; austin TX 78744
• Manufacturer (Section G): ORIGEN BIOMEDICAL, INC; 7000 burleson rd.; bldg. d; austin TX 78744
• Manufacturer Contact: kiersten soderman ; 7000 burleson rd.; bldg. d; austin, TX 78744 ; 5126157606
• MDR Report Key: 8472110
• MDR Text Key: 146350662
• Report Number: 1646848-2019-00013
• Device Sequence Number: 0
• Product Code: DWF
• Reporter Country Code: US
• PMA/PMN Number: K113869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/01/2019

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: 11/30/2015
• Device Model Number: VV13F
• Device Lot Number: K17389
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/30/2015
• Initial Date FDA Received: 04/02/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1