MYNX CONTROL

Description of Event or Problem

AS REPORTED, THE BALLOON OF A 6F/7F MYNX CONTROL VASCULAR CLOSURE DEVICE (VCD) DEVELOPED A LEAK WHILE THE PHYSICIAN WAS PULLING THE MYNX DEVICE BACK IN AN EFFORT TO GAIN PROPER TENSION AND DEPLOY THE MYNX SEALANT. THE DEVICE AND SHEATH CAME COMPLETELY OUT OF THE PATIENT. MANUAL PRESSURE WAS THEN HELD FOR LESS THAN 30 MINUTES TO SUCCESSFULLY ACHIEVE HEMOSTASIS. THERE WAS NO REPORTED PATIENT INJURY. THE BALLOON LOST PRESSURE AFTER BEING PULLED TO THE ARTERIOTOMY. THERE WAS NO VISIBLE DAMAGE TO THE SHEATH OR ITS DISTAL END AFTER REMOVAL. THE VASCULAR INTERVENTION WAS COMPLETED VIA RETROGRADE ACCESS. THE PHYSICIAN INSERTED THE DEVICE THROUGH A 6F NON-CORDIS SHEATH, HOOKED THE SIDEARM OF THE SHEATH, AND INFLATED THE MYNX BALLOON. THERE WAS NO PRIOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA), STENT, OR VASCULAR GRAFT IN THE COMMON FEMORAL ARTERY. THE VESSEL DIAMETER WAS VERIFIED TO BE AT LEAST 5 MM. CALCIUM WAS NOTED TO BE PRESENT IN THE PATIENT¿S ILIAC AND COMMON FEMORAL ARTERIES NEAR THE ACCESS SITE. THE USER WAS TRAINED ON THE DEVICE, AND THE DEVICE WAS PREPARED AND STORED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WILL BE RETURNED FOR EVALUATION.

Additional Manufacturer Narrative

DUE TO SYSTEM LIMITATIONS, SECTION H6 REQUIRED TO INPUT TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS FOR AN INITIAL REPORT. PENDING ADDITIONAL INFORMATION TO COMPLETE INVESTIGATION.THIS DEVICE IS AVAILABLE FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.