MAUDE Adverse Event Report: ORIGEN ORIGEN REINFORCED DUAL LUMEN CATHETER

Model Number VV28F

Device Problems Disconnection (1171); Device Handling Problem (3265)

Patient Problem Blood Loss (2597)

Event Date 11/23/2016

Event Type  malfunction  

Manufacturer Narrative

Origen conducted destructive testing on catheter samples from the same lot, which remained in origen's possession.Through this testing, origen has only been able to reproduce the failure by place a tube clamp on the tubing close to the catheter hub.Clamping in this area breaks the adhesive bond and results in the tubing disconnecting from the hub.A direct outward pull force without compressing the tubing with a clamp did not result in a disconnect, even with a twisting force applied in conjunction with the pull.The clamping-induced failure did not occur in every sample testing.This may be due to the fact that, while the failure can be induced, it is more likely occur during use beyond that recommended in the instructions for use, which limits duration to 6 hours.The customer reporting the failure had the patient on ecmo using the catheter for 14 days continuously with intermittent placement and removal of the tube clamp.Additionally, other sizes of catheters were tested and the same or better results were found: clamping on the tube close to the hub caused the tube to pull away from the hub; however, the tubing did not disconnect from the hub.Origen verified that the correct adhesive had been used on this lot of catheters using ftir spectroscopy.To date, three thousand five hundred sixteen (3516) origen rdlc catheters have been distributed to customers.Three catheters have been reported to origen with tubing disconnects (2 from the recall and 1 from this event.) based on the quantity distributed yield a field failure rate of 0.09% for this event.The frequency identified in the risk assessment is 2 (could occur but not expected).The risk assessment, prior to this event, identified tensile pulling force as the potential cause of a tubing disconnect failure.The failure mode caused by tube compression by a clamping force was not identified.The customer reported using the catheter for 14 days, which far exceeds the origen ifu limitation of up to 6 hours.Origen is continuing to investigate alternative adhesives that may reduce the occurrence of tubing disconnects; however, the product risk assessment frequency of 2 is in alignment with actual occurrence of 0.09% even at the extended duration reported by customers.The origen ifu has a warning/precaution section that provides informaiton on clamping, which is thought to have induced this failure: clamping: do not clamp the tip portion of the catheter.Use only smooth-jawed forceps for clamping and clamp only near the middle of the clear tubing.Repeated clamping in the same site may weaken the tubing; change the position of the clamps slightly to prolong the life of the tubing.Do not clamp near the connectors, as they may fracture.A technical bulletin with images is now provided in each catheter shipment to ensure customers are clear on correct clamping location.

Event Description

On (b)(6) 2016, origen received a customer notification from (b)(6) that they had a 28f catheter from which one of the clear tubes disconnected from the hub toward the end of a 14 day ecmo run (vv28f, lot n18487).The hospital representative (b)(6) reported that the patient was about to come off ecmo and had been extubated.When the patient coughed, the clear tube on the drainage side of the catheter disconnected.As hospital staff was present, they immediately capped the drainage line and re-plumbed the circuit for just the femoral drainage, which was also in place.The hospital's risk management team required the catheter by retained by the hospital, but photos were provided to origen.The defective origen catheter was replaced by a second unit of the same lot number.

• Brand Name: ORIGEN REINFORCED DUAL LUMEN CATHETER
• Type of Device: REINFORCED DUAL LUMEN CATHETER
• Manufacturer (Section D): ORIGEN; 7000 burleson road; building d; austin TN 78744
• Manufacturer (Section G): ORIGEN BIOMEDICAL INC.; 7000 burleson road; building d; austin TN 78744
• Manufacturer Contact: jackie jaskula ; 7000 burleson road; building d; austin, TN 78744 ; 5126157606
• MDR Report Key: 6815989
• MDR Text Key: 83534970
• Report Number: 1000160256-2017-00002
• 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: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 04/05/2017

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: Physician
• Device Expiration Date: 08/30/2018
• Device Model Number: VV28F
• Device Catalogue Number: VV28F
• Device Lot Number: N18487
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/30/2016
• Initial Date FDA Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/05/2014
• 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): Required Intervention