OPTISITE ARTERIAL CANNULA

Additional Manufacturer Narrative

H11 ADDITIONAL MANUFACTURER NARRATIVE (INCLUDING H3 FINDINGS THUS FAR): THE DEVICE WAS RETURNED FOR EVALUATION. CUSTOMER REPORT OF EXPOSED WIRE WAS CONFIRMED. AS RECEIVED, 4MM SECTION OF WIRE FROM THE WIRE REINFORCEMENT OF THE CANNULA WAS FOUND TO BE EXPOSED AND PROTRUDING FROM THE CANNULA BODY 15MM FROM DISTAL TIP. WIRE APPEARED TO MATCH THE LENGTH OF THE GROOVE. AS RECEIVED, CANNULA WAS OBSERVED TO HAVE A KINK ALONG THE WIRE-REINFORCEMENT SECTION OF THE CANNULA BODY, APPROXIMATELY 5.5" FROM THE DISTAL END. NO OTHER VISUAL DAMAGE, CONTAMINATION, OR OTHER ABNORMALITIES WERE FOUND TO THE CANNULA. PHOTOS ATTACHED WERE CONSISTENT WITH LAB FINDINGS. THE REPORTED EVENT IS PENDING FURTHER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IN A TIMELY MANNER ONCE THE INVESTIGATION HAS BEEN COMPLETED OR NEW INFORMATION BECOMES AVAILABLE. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

Description of Event or Problem

EDWARDS RECEIVED A REPORT STATING THEY HAD THE WIRE POKE THROUGH THE PLASTIC YESTERDAY DURING A CASE IN REFERRING TO AN OPTI16 CANNULA. NOTHING WAS OBSERVED BY THE SCRUB NURSE WHEN RECEIVING THE CATHETER. THE EVENT OCCURRED DURING INSERTION JUST PRIOR TO ENTERING THE VESSEL (NO DEPTH WITHIN THE AORTA), AND THEN THEY REPLACED IT WITH ANOTHER OPTI16 FROM THE SAME LOT NUMBER. NO PATIENT ISSUES REPORTED. THE PACKAGE HAD NO VISIBLE DAMAGE. A CUSTOMER LETTER IS REQUESTED, AND THE DEVICE IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED CONCERNING STORAGE CONDITIONS: OR TEMPERATURE RANGE 65-75; HUMIDITY LEVEL BETWEEN 20-60%; EXACT VALUES ON DAY OF EVENT ARE ASSUMED TO BE WITHIN THE NORMAL RANGES.

Additional Manufacturer Narrative

G3/ G6/H2 UPDATED WITH AWARENESS AND FOLLOW UP INFORMATION H6 CODES UPDATED FOR CURRENT FOLLOW UP REPORT (INCLUDING INVESTIGATION TYPE, INVESTIGATION FINDINGS, AND INVESTIGATION CONCLUSIONS) H11 ADDITIONAL NARRATIVE: NO NEW INFORMATION IN ADDITION TO INITIAL PRODUCT EVALUATION SUBMITTED WITH INITIAL REPORT. NO REWORK, DEVIATION, OR NONCONFORMANCE WAS FOUND TO BE ASSOCIATED WITH THE LOT. NO STERILIZATION DEFICIENCY REPORT. TENSILE TESTING ALL NORMAL. WELDING AND TIPPING RECORDS SHOW SETTINGS WERE WITHIN SPECIFICATION. AN INVESTIGATION WAS OPENED AT THE SUPPLIER TO MORE THOROUGHLY INVESTIGATE THE ISSUE OUTSIDE OF THE COMPLAINT INVESTIGATION. AN AWARENESS COMMUNICATION WAS ALSO CONDUCTED AT THE SUPPLIER. BASED ON THE AVAILABLE INFORMATION, THE COMPLAINT HAS BEEN CONFIRMED AND THERE IS SUFFICIENT EVIDENCE TO CONFIRM A MANUFACTURING DEFECT. THE REPORTED DEFECT IS SUSPECTED TO BE A SUPPLIER MANUFACTURING ISSUE. THERE IS NO EVIDENCE OF AN INTERNAL EDWARDS DEFECT AT THIS TIME. AN ADDITIONAL INVESTIGATION HAS BEEN REQUESTED AND IS UNDERWAY AT THE SUPPLIER. EDWARDS WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.