ARROW VASCULAR UNKNOWN

Description of Event or Problem

DURING THE COURSE OF THE INVESTIGATION, AN ADDITIONAL SAMPLE RETURN WAS RECEIVED FROM A SEPARATE COMPLAINT INVOLVING A CATHETER AND SPRING WIRE GUIDE (SWG). UPON EVALUATION, THE RETURNED SWG WAS OBSERVED TO BE UNRAVELED. IT SHOULD BE NOTED THAT THIS SAMPLE WAS NOT CONFIRMED TO BE ASSOCIATED WITH THE REPORTED EVENT. GOOD FAITH EFFORTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED DEVICE ISSUE. A TOTAL OF THREE DOCUMENTED ATTEMPTS WERE MADE TO CONTACT THE USER FACILITY; HOWEVER, NO RESPONSE OR ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

(B)(4).