RHV

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. THE PRODUCTION RECORDS FOR THIS PRODUCT COULD NOT BE REVIEWED AND A SIMILAR COMPLAINT QUERY COULD NOT BE PERFORMED BECAUSE THE PART NUMBER AND/OR LOT NUMBER WERE NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. BASED ON THE INFORMATION PROVIDED AND BECAUSE THE DEVICE WAS NOT RETURNED FOR ANALYSIS, IT IS UNKNOWN WHAT MAY HAVE CAUSED THE REPORTED LOOSE OR INTERMITTENT CONNECTION. THEREFORE, THE INVESTIGATION DETERMINED THAT A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE D4: THE UDI NUMBER IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED.

Description of Event or Problem

IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT AN UNSPECIFIED LESION. A ROTATING HEMOSTATIC VALVE (RHV) WAS ATTEMPTED TO BE USED HOWEVER, THE DEVICES WERE UNABLE TO STAY LOCKED ON THE RHV SIDE PORT. A NEW ACCESSORY WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.