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

Model Number PCTA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Atrial Perforation (2511)

Event Type  Injury  

Manufacturer Narrative

There had been no reports of atrial perforation on the reinforced dual lumen catheter, all sizes as of the date of this report out of 1,106 catheters placed.The pct kit ifu for positioning of the catheter states the following regarding positioning: "continue advancing the guidewire to the mid-right atrium.Note: the guidewire is marked at 10, 20, and 30 cm distances from the j-tip.Use echo, radiography or other means to confirm position." the catheter ifu states the following regarding positioning: "use x-ray or echo to verify that the catheter tip is positioned in the nid right atrium before use.Incorrect insertion may result in puncture of the right atrium or vein." on september 12, 2014, dr.(b)(6) reported that he believed the event to be a result of "pilot error".

Event Description

(b)(6) children's hospital reported that the extended surgeon group had two atrial perforations with the new wire-reinforced origen catheter during the past two weeks ((b)(6) 2014 - (b)(6) 2014).

• 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: 8415482
• MDR Text Key: 138647984
• Report Number: 1646848-2019-00003
• 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
• 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: PCTA
• Device Catalogue Number: PCTA
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2014
• 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): Life Threatening; Required Intervention