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

Model Number VV13F

Device Problem Material Too Rigid or Stiff (1544)

Patient Problems Cardiac Arrest (1762); Cardiopulmonary Arrest (1765); Perforation (2001)

Event Date 04/07/2017

Event Type  Injury  

Manufacturer Narrative

Product was not returned to origen for evaluation so definitive root cause was not able to be determined.Discussion with the surgeon revealed probable cannulation error with catheter placed too low.Surgeon confirmed that perforation occurred during guidewire placement before the catheter was introduced.

Event Description

A (b)(6) month old patient was cannulated on vv ecls on (b)(6) 2017 via a 13 french origen cannula in the right internal jugular vein.The run went extremely well and the patient was getting ready to be decannulated on (b)(6) 2017.In preparation for decannulation, a gel pillow was removed from behind the patient's head and the chin moved forward.The patient went asystolic and the flow went down to 0 on the cardiohelp.After a few seconds, it became apparent that there was a perforation in the heart and the patient was in cardiac arrest.The patient was coded and cannulated via v-a.After the patient was stabilized, the pediatric surgeon looked at the old 13 french origen cannula and noted that it seemed extremely stiff.

• Brand Name: ORIGEN REINFORCED 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: 8415474
• MDR Text Key: 138647904
• Report Number: 1646848-2019-00004
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Model Number: VV13F
• Device Catalogue Number: VV13F
• Device Lot Number: M18182
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2017
• Initial Date FDA Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/31/2013
• 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 Outcome(s): Life Threatening; Required Intervention
• Patient Age: 13 MO