NEEDLE COAXIAL INTRODUCER 15G X10CM

Description of Event or Problem

A PRODUCT COMPLAINT WAS RECEIVED REGARDING AN INCIDENT INVOLVING A UNIVERSAL COAXIAL INTRODUCER NEEDLE ((B)(4)). ON (B)(6) 2012, THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED BY THE CUSTOMER: THIS PROCEDURE INVOLVES TWO MAJOR STEPS. UNDER CT GUIDANCE, THE RADIOLOGIST INSERTS A COAXIAL INTRODUCER NEEDLE 15G X 10CM TO THE PERIPHERY OF THE TARGET LESION. AFTER THAT, RADIOLOGY INSERTS ANOTHER TEMNO BIOPSY NEEDLE 16G X 15CM THROUGH THE CANNULA OF INTRODUCER NEEDLE FOR THE COLLECTION OF THE SAMPLING TISSUE. THE PROCEDURE WAS LARGELY UNEVENTFUL AT THE FIRST AND SECOND PASS. DURING THE THIRD PASS OF THE BIOPSY, THE RADIOLOGIST FELT THE COAXIAL INTRODUCER NEEDLE BROKEN AT THE TIME OF INSERTION. ON (B)(6) 2012, THE CUSTOMER INDICATED THAT THE BROKEN NEEDLE WAS SURGICALLY REMOVED FROM THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

Additional Manufacturer Narrative

(B)(4). EVALUATION SUMMARY: THE SAMPLE (COAXIAL NEEDLE) WAS RECEIVED FOR EVALUATION. DURING VISUAL INSPECTION, IT WAS OBSERVED THAT THE NEEDLE WAS BROKEN IN TWO PIECES AND ONE PART OF THE NEEDLE WAS DAMAGED. THIS WAS PROBABLY CAUSED DURING THE REMOVAL OF THIS PART FROM THE PATIENT. THEREFORE, THE REPORTED CONDITION WAS CONFIRMED. A REVIEW OF APPLICABLE MANUFACTURING PROCEDURES AND QUALITY PLAN INSPECTIONS DID NOT IDENTIFY ANY ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. THE COMPLAINT DATA WAS REVIEWED AS WELL, AND NO TREND WAS NOTED. THE MOST PROBABLE ROOT CAUSE OF THIS INCIDENT COULD NOT BE DETERMINED BASED ON THE SAMPLE ANALYSIS. HOWEVER, IT IS CONSIDERED THAT BREAKAGE COULD BE AS A RESULT OF THE MOVEMENT OF THE PATIENT DURING THE BIOPSY PROCEDURE. THIS FAILURE IS BEING MONITORED TO IDENTIFY THE NEED FOR FURTHER ACTIONS.