MYNX CONTROL VENOUS

Description of Event or Problem

AS REPORTED, THE FILM JUST ABOVE THE BALLOON OF A 6F¿12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) CRUMPLED DURING INTRODUCTION INTO THE SHEATH, AND THE SEALANT CRUMBLED OUT. THE DEVICE WAS DISCARDED, AND ANOTHER 6F¿12F MYNX CONTROL VENOUS VASCULAR CLOSURE DEVICE (VCD) WAS USED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS USED IN AN AFFERA ATRIAL FIBRILLATION (AFIB) ABLATION PROCEDURE. THE DEVICE WAS PREPARED CORRECTLY PRIOR TO USE. THE MYNX VASCULAR CLOSURE DEVICE (VCD) WAS USED DURING AN INTERVENTIONAL ABLATION PROCEDURE WITH AN ANTEGRADE APPROACH. THE DEPLOYER WAS MYNX CERTIFIED. THE DEVICE WAS STORED AND PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE DEVICE WAS USED FOR VENOUS CLOSURE. ULTRASOUND WAS USED TO OBTAIN VASCULAR ACCESS INITIALLY BUT WAS NOT USED DURING CLOSURE. THE DEVICE WAS REMOVED FROM THE PACKAGING BY THE HANDLE. 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.