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

Model Number VV23F

Device Problem Malposition of Device (2616)

Patient Problems Death (1802); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Type  Death  

Manufacturer Narrative

As the device was not returned and no lot number was available, it was not possible to determine root cause of the event.Involvement of the origen catheter in the event was neither confirmed nor ruled out.If any additional information becomes available on this case, origen will reopen the complaint for further investigation.

Event Description

Perforation of the right atrium while using a 23 french dual lumen catheter.Dr.(b)(6) reported that the patient died of cardiac tamponade and an autopsy found three perforations in the right atrium.There was difficulty in seeing the catheter on ultrasound and healthcare team was not certain if the catheter had been placed too low.The cannulating surgeon reported that he felt he may have inserted the guidewire too deeply and the ultrasound operator had a great deal of difficulty in locating the catheter in the atrium.Dr.(b)(6) thought the atrial puncture could have occurred from either initial cannulation or mis-positioning of the catheter later, but she did note that the leakage was not noticed until late in the case.She thought the re-positioning of the patient may have played a role as well.Dr.(b)(6) indicated that the leakage seemed to have caused tamponade, and noted that this could possibly have come from a slow leak started at cannulation.

• 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: 8415477
• MDR Text Key: 138641623
• Report Number: 1646848-2019-00001
• 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
• 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 Model Number: VV23F
• Device Catalogue Number: VV23F
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/01/2016
• Initial Date FDA Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death