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Patient 1
WE HAVE RECEIVED AND EVALUATED THE COMPLAINT DEVICE. WE WERE ABLE TO CONFIRM THE REPORTED FAILURE. WE FOUND THAT ONE OF THE BLADES DID NOT INSERT INTO THE RETAINER WHEN THE CENTERING HOOPS WERE CLOSED SINCE THE HOOP OF THE SAME BLADE WAS SLIGHTLY BENT AND WAS EXPOSED OUT OF THE SHEATH. WHEN THE TIP OF THE BLADE WAS VIEWED UNDER MICROSCOPE, WE FOUND THAT THE TIP OF THE BLADE WAS BENT AT THE NECK ( DISTALLY). THIS COULD HAVE OCCURED IF THE BLADE GOT STUCK ON THE VEIN E.G. SIDE BRANCHES DURING THE PROCEDURE AND THE PHYSICIAN TRIED TO PULL AND ROTATE THE BLADES AT THE SAME TIME. THE PHYSICIAN HAD ALSO MENTIONED IN THE COMPLAINT DESCRIPTION THAT THE DEVICE WAS STUCK WHILE WITHDRAWING FROM THE PATIENT'S VEIN. WE HAVE ALSO RECEIVED TWO UNITS OF THIS LOT FROM THE SAME HOSPITAL. WHEN ONE OF THE UNIT WAS INSPECTED, WE DID NOT FIND ANY DEFECT WITH THIS DEVICE. ALL OF THE BLADES WERE ABLE TO FULLY ENTER AND EXIT THE RETAINER. WHEN WE TRIED TO RECREATE THE ISSUE BY MANUALLY HOLDING THE BLADES AND FORCEFULLY CLOSING THE SHEATH, WE WERE ABLE TO RECREATE THE ISSUE BUT THE BLADES WERE MORE DAMAGED AT THE PROXIMAL SIDE RATHER THAN DISTAL SIDE THAT WAS OBSERVED IN THE COMPLAINT DEVICE. OUR LOT HISTORY RECORDS REVIEW DID NOT REVEAL ANY DISCREPANCIES RELATED TO THE COMPLAINT EVENT EITHER IN THE MANUFACTURING OR PACKAGING PROCESSES. PLEASE NOTE THAT WE DO CONDUCT 100% INSPECTION OF THE BLADE ASSEMBLY DURING THE MANUFACTURING PROCESS. ALTHOUGH WE ARE INCONCLUSIVE ABOUT THE ROOT CAUSE OF THE ISSUE, IT IS LIKELY THE DEFECT OCCURED AS A RESULT OF EXCESSIVE FORCE AND MANIPULATION BY THE USER DURING ATTEMPTED SHEATHING OF THE DEVICE. THERE WAS NO INJURY TO THE PATIENT AS THE RESULT OF THIS INCIDENT.