RHV

Additional Manufacturer Narrative

MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. D4: THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. THE ADDITIONAL DEVICES REFERENCED IN B5 IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBER.

Description of Event or Problem

IT WAS REPORTED THAT THE DURING TO TREAT A STROKE ALERT AND THROMBECTOMY WAS PREFORMED 6 UNSPECIFIED ROTATING HEMOSTATIC VALVE (RHV) WOULD NOT REMAIN TIGHT ONTO THE TWO WAY (STOPCOCK). THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

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 WAS NOT REPORTED, AND THE DEVICE WAS NOT RETURNED. IT IS POSSIBLE THAT THE DEVICES WERE NOT PROPERLY ALIGNED AND/OR NOT FULLY CONNECTED/TIGHTENED WHILE ATTEMPTING TO CONNECT AND/OR THE PORT OF THE DEVICE BEING CONNECTED WAS COMPROMISED RESULTING IN THE REPORTED LOOSE/INTERMITTENT CONNECTION; HOWEVER, AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS, THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES CANNOT BE DETERMINED. BASED ON THE REPORTED INFORMATION AND THE RESULTS OF THE COMPLAINT INVESTIGATION, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.