RHV

Description of Event or Problem

IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE LEFT ANTERIOR DESCENDING ARTERY. THE ROTATING HEMOSTATIC VALVE (RHV) CAP WAS SPINNING FREELY AND WOULD NOT LOCK IN PLACE. THE PROCEDURE WAS COMPLETED USING A DIFFERENT DEVICE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT.

Additional Manufacturer Narrative

A VISUAL INSPECTION AND FUNCTIONAL TESTING WAS PERFORMED ON THE RETURNED DEVICE. THE REPORTED LOOSE OR INTERMITTENT CONNECTION WAS UNABLE TO BE CONFIRMED. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A SPECIFIC ISSUE. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES. AS THE REPORTED LOOSE OR INTERMITTENT CONNECTION WAS UNABLE TO BE CONFIRMED DURING THE RETURN ANALYSIS, IT IS POSSIBLE THAT THE DEVICES WERE NOT PROPERLY ALIGNED AND/OR NOT FULLY CONNECTED/TIGHTENED WHILE ATTEMPTING TO CONNECT, RESULTING IN THE REPORTED LOOSE/INTERMITTENT CONNECTION; HOWEVER, THIS CANNOT BE CONFIRMED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.

Description of Event or Problem

SUBSEQUENT TO THE INITIALLY FILED MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED. A SECOND RHV WAS USED DURING THE PROCEDURE AND THE SAME ISSUE OCCURRED. NO ADDITIONAL INFORMATION WAS PROVIDED.