Merit Medical ReSolve Manual Del Usuario página 2

Root Cause and Corrective Action

The root cause has not been determined. Corrective action beyond the field action has not
been determined at this time.
Removal Actions

Merit initiated the recall on January 16, 2013. On January 16, sales representatives began
contacting each physician and user facility that had been provided product.

Written communications were drafted and distribution began on 24 January 2013.

Merit also assessed its on-hand inventory for affected products. The affected products have
been quarantined at Merit's facilities.
Complaint Details

To date, Merit has received one (1) product complaint from a physician in Denmark. There
have not been any reports of injury or illness reported with the complaint.

The complaint stated the following: The user reported that during a routine drainage catheter
exchange in the treatment for intrahepatic strictures, the physician noticed that the device
had fractured into several pieces under fluoroscopic visualization. A guide wire was inserted
and used to straighten the pig tail. The guide wire exited a fracture point of the catheter near
the tip. The majority of the device was removed over the wire while holding the suture. The
suture near the pigtail was cut which allowed the distal tip of the catheter to remain in the
patient. The tip was left in the patient to pass normally through the bowel. The physician
visualized the tip of the catheter under fluoroscopy to be moving distally via peristalsis. The
device was exchanged without further incident. The patient was discharged as normal. No
reports of harm or injury.
Distribution Details:

See Attachment A.
Field Safety Notice

Final Field Safety Notice (FSN) proposal is enclosed per Attachment B.
Product Labeling

In addition, product labeling is enclosed per Attachment C.
It is Merit's objective to finalize recall activities within 30 days. Please do not hesitate to contact me if
you have questions or need additional information.
Sincerely,
Merit Medical Ireland Ltd.
Mark Mullaney, Regulatory Affairs Manager
Parkmore Business Park West, Galway, Ireland
Phone #: +353 91 703 761; Fax #: +353 91 771 888; E-mail: mmullaney@merit.com
Confidential Information
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