TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE PACK (2016-04-25)

Starting date:

April 25, 2016

Posting date:

April 27, 2016

Type of communication:

Medical Device Recall

Subcategory:

Medical Device

Hazard classification:

Type I

Source of recall:

Health Canada

Issue:

Medical Devices

Audience:

General Public, Healthcare Professionals, Hospitals

Identification number:

RA-58104

• Reason
• Affected products

Affected products 

A. TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT PROCEDURE PACK

Reason

There is an increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. Environmental conditions, such as storage temperature, humidity, and the use of vaporized hydrogen peroxide (VHP) for whole-room decontamination within healthcare facilities, may be contributing to the occurrence. There may be other undetermined contributors to this issue and continue to investigate. 

Potential adverse events that may occur as a result of catheter polymer degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.

Affected products