RHV

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. THE ADDITIONAL DEVICE REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A HEAVILY CALCIFIED, HEAVILY TORTUOUS LEFT ANTERIOR DESCENDING CORONARY ARTERY. DURING AN ATTEMPT TO CONNECT 2 DIFFERENT ROTATING HEMOSTATIC VALVE (RHV) TO A NON-ABBOTT CATHETER, THE Y CONNECTOR OF BOTH RHVS WERE LOOSE AND WOULD LOCK IN PLACE. AN UNSPECIFIED DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 LOT SPECIFIC ISSUE. BASED ON THE INFORMATION PROVIDED AND BECAUSE THE DEVICE WAS NOT RETURNED FOR ANALYSIS A DEFINITIVE CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. D9 CORRECTION: DEVICE AVAILABLE FOR EVALUATION UPDATED FROM YES TO NO.