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

Model Number VV19F

Device Problems Nonstandard Device (1420); Positioning Problem (3009)

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

Event Date 11/25/2017

Event Type  malfunction  

Manufacturer Narrative

This is being submitted in response to fda report mw5073744.This report is being prepared and submitted by the manufacturer in response to the medwatch report noted above.

Event Description

An origen 19 french ecmo catheter was reported to place patient on ecmo.It was determined, after placement, that it was not radiopaque and the ability to identify proper placement after insertion was compromised because it was not visible on x-ray.

• 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: 8415479
• MDR Text Key: 138975677
• Report Number: 1646848-2018-00005
• 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
• Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 01/07/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2019
• Device Model Number: VV19F
• Device Catalogue Number: VV19F
• Device Lot Number: P18971
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/28/2017
• Initial Date FDA Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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): Other