Regulator issues two medical device warnings amid patient safety fears


MitraClip Clip Delivery System from Abbott Vascular and Lumenis\' VersaCut Morcellator control box at centre of MHRA alerts

Patient safety fears have led to the publication of two Medical Device Alerts.

The Medicines and Healthcare products Regulatory Agency (MHRA) has issued the warnings following incidents involving two appliances.

The first is the MitraClip Clip Delivery System manufactured by Abbott Vascular.

The alert follows concern over the risk of death or serious harm to patients due to the possibility of the actuator knob on the Clip Delivery System (CDS) being turned in the wrong direction, preventing successful deployment of the clip and leading to the need for open surgical repair.

The MHRA has been notified by the manufacturer that there have been four reports, including one in the UK, of the knob being turned clockwise instead of anti-clockwise when attempting to disengage and deploy the clip from the CDS. Turning it incorrectly could cause a fracture of the CDS internal assembly, leading to an inability to control the release of the clip from the CDS. Since the clip may already have a firm grasp on the mitral valve at this point, open surgery may be required to disengage it.

The UK incident led to the need for emergency open surgical repair. The bulk of the CDS could only be removed from the clip using surgical boltcutters and the remaining shaft of the CDS unscrewed from the clip using forceps. Unfortunately, the patient died a week later following renal complications.

In order to prevent further incidents of this type, the manufacturer issued a Field Safety Notice on 27 February providing advice. In addition, new devices will have a blue directional arrow on the actuator knob to help operators visualise the correct direction of turn. The manufacturer has also confirmed it intends to make a number of design changes which should ultimately make it impossible to turn the knob in the wrong direction. The implementation of the final stages of the design changes will not, however, be completed for up to two years. In the meantime operators are being urged to ensure they follow instructions for use.

Click here for the alert.

The second warning refers to the VersaCut Morcellator control box model 0636-470-01 manufactured by Lumenis.

It covers all devices manufactured since May 1998 and relates to a risk of air embolism if the tubing from the handpiece to the aspiration pump is connected incorrectly.

The safety warning urges trusts to identify all affected devices and attach the labels indicating correct tubing configuration, provided with the manufacturer’s earlier Field Safety Notice , to the front and top of the control box housing. They should also destroy previous versions of the Operator Manual and replace with current manual.

Sign up for your free email newsletter

Click here for the warning.