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

Model Number VV15F

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem High Blood Pressure/ Hypertension (1908)

Event Date 03/18/2016

Event Type  malfunction  

Manufacturer Narrative

The 15f catheter was received back and it appears to have been sucked flat by suction pressure on the drainage side.It was also badly kinked, and the reinfusion lumen was partially obstructed as well.The white polyurethane catheters are not reinforced and for use with roller pumps only.The instructions for use supplied with that catheter state, "suction: warning: the unreinforced catheter may collapse if suction pressure less than -50 mm hg is applied to the drainage lumen".

Event Description

Patient placed on ecmo on (b)(6) 2016.Cannulation went smoothly.Surgeons did not feel the 18f would fit so a 15f was placed.Initial flows were 1.14 with rpms of 3465.Negative pressures -100 (the box used only measures to -100).Volume given to patient and antihypertensives started.Waited for patient to settle and hoped that flows and rpms would correct.Blood pressure came down and there was never really any improvement in rpms or flows.The kink was not discovered until the cannula was removed.Cannula was changed on (b)(6) 2016 to the 18f, reinforced cannula.The same issue occurred and it has collapsed as well.It flattened outside the incision and will need to change it.At this point after 2 cannulas with the same issues, user believes it is something about the patient.Circuit is very clean, no issues with anticoagulation and the 18f should be the correct size for the patient and flows.

• 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: 8472109
• MDR Text Key: 146350361
• Report Number: 1646848-2019-00012
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113869
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• 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

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: VV15F
• Device Lot Number: M17983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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
• Patient Weight: 13