MDA/2006/071 - Radial artery introducer sets: William Cook Europe Flexor® Check-Flo® Micropuncture® Radial Artery Access Introducer Sets with AQ® Hydrophilic Coating

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Document details:

Type:	Medical Device Alert
Series No:	n/a
Audience:	Healthcare professionals
Published:
Format:	Electronic and paper
Size:	A4
Pages:	5
Price:	Free
ISBN/ISSN:
Author:
Copyright:	Crown

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Please note: In October and November 2010, the MHRA moved from its Market Towers address to a new location on Buckingham Palace Road. Please go to the contact us section of the website for updated contact details.

Page 1

Issued: 18 December 2006 at 13:30

Ref: MDA/2006/071

	Immediate action
	Action
	Update
	Information request

Device:
Radial artery introducer sets: William Cook Europe Flexor® Check-Flo® Micropuncture® Radial Artery Access Introducer Sets with AQ® Hydrophilic Coating

Problem:
The manufacturer has received reports of inflammatory responses at the access site of a number of patients following use of this device. The cause of these events has not been identified

>Page 2

Action by:
All clinicians involved in arterial catheterisation

Action:
Ensure all users are:

aware of the potential risks associated with the use of this device, as outlined in the attached customer letter
following the guidance in the attached letter which includes:
- using a small incision in the skin to facilitate sheath insertion
- firmly wiping the length of the sheath with sterile saline wetted gauze prior to insertion
adhering to local infection control policy particularly when using the wetted gauze.

Ensure procedures are in place to report any inflammatory response associated with the use
of this device to the manufacturer William Cook and the MHRA.

Distributed to:

NHS trusts in England
Healthcare Commission (CHAI)

– Chief Executives*
– Headquarters

* via CE Bulletin

>Page 2

Contacts:
Details of manufacturer contacts and MHRA contacts for technical and clinical aspects.
Change of address or removal from address list for Healthcare Commission.

>Pages 2-3

Appendix:
Cook customer letter.

>Pages 4-5

Action deadlines for the Safety Alert Broadcast System (SABS)
Deadline (action underway): 18 January 2007	Deadline (action complete): 18 February 2007

Download documents:

MDA/2006/071 - Radial artery introducer sets: William Cook Europe Flexor® Check-Flo® Micropuncture® Radial Artery Access Introducer Sets with AQ® Hydrophilic Coating (641Kb)

Page last modified: 18 December 2006