FDA Adverse Event Malfunction Summary report: N

ORIGEN REINFORCED DUAL LUMEN CATHETER

MDR report key: 8472108 · Received April 2, 2019

Report

Report Number: 1646848-2019-00011
Event Type: Malfunction
Date Received: April 2, 2019
Report Date: April 1, 2019
Manufacturer: ORIGEN BIOMEDICAL, INC
Product Code: DWF
PMA / PMN Number: K113869
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: 501

Narratives

Additional Manufacturer Narrative · 1

THE CATHETER WAS RETURNED AND SANITIZED AND VISUALLY INSPECTED. THERE IS A RESIDUAL KINK NEAR THE HUB AND IT APPEARS THAT THE KINK WAS THE RESULT OF TWISTING THE CATHETER TIP. ENGINEER WAS ABLE TO RECREATE THE KINK BY HOLDING THE HUB AND STRONGLY TWISTING THE TIP. ONE WOULD SURMISE THAT THE NATURE OF THE IJV COULD NOT SUPPORT SUCH TORSION, BEING LUBRICATED WITH BLOOD, SO MANUFACTURER HAS NO EXPLANATION HOW THIS COULD HAVE HAPPENED. THE AMOUNT OF TORQUE TO PRODUCE SUCH A KINK IS SUBSTANTIAL, AND THE REINFORCING BRAIDING IS NOT DESIGNED TO WITHSTAND THIS MUCH TORQUE. THIS IS ALSO THE FIRST REPORT EVER OF THIS TYPE OF KINK IN THE REINFORCED CATHETER.

Description of Event or Problem · 1

A 13F CATHETER WAS INSERTED VIA DIRECT CUT DOWN TO PATIENT. THE SURGEON HAS BEEN PLACING ORIGEN CATHETERS FOR ABOUT 20 YEARS. THE CATHETER WENT IN WELL WITHOUT ANY INCIDENCE. THERE WAS A GOOD FLOW AT 480 ML/M. THE USER(S) WENT TO CLOSE THE WOUND AND NOTICED THAT THEY HAD POSITIONAL FLOW AND AFTER 5 MINUTES THEY HAD NO FLOW TO THE PATIENT. USER REMOVED THE CATHETER AND REPLACED IT WITH AN AVALON 13F. USER NOTED THAT THERE WAS A KINK ON X-RAY AND WILL SEND A COPY OF THE PHOTO FOR REFERENCE. USER INSERTED THE CATHETER ALL THE WAY TO THE HUB. THE CATHETER KINKED INTERNALLY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
269565	ORIGEN REINFORCED DUAL LUMEN CATHETER	VV ECMO CATHETER	DWF	ORIGEN BIOMEDICAL, INC	VV13F	N18573

Patients

Seq	Age	Sex	Outcome	Treatment
1