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Additional Manufacturer Narrative

THIS INCIDENT WAS NOT REPORTED DIRECTLY TO EKOS BY THE USER FACILITY, SO THE INVESTIGATION WAS BASED ON THE MEDWATCH FORM COMPLETED BY THE USER FACILITY. EKOS INVESTIGATED THE RETURNED CATHETER AND DOWNLOADED THE LOG FILE STORED IN THE CONTROL UNIT AT THE USER FACILITY. THE STORED DATA FOR THE DEVICE SERIAL # REPORTED WAS RETRIEVED AND EXAMINED. THE LOG FILE DATA DOES NOT MATCH THE EVENT DESCRIPTION PROVIDED BY THE USER FACILITY. THE LOG FILE INDICATES THAT FOLLOWING PLACEMENT OF THE DEVICE IN QUESTION, THE INSTRUMENT WOULD NOT RECOGNIZE THE DRUG DELIVERY CATHETER. THE CATHETER WAS REMOVED AND REPLACED AND THE SYSTEM WORKED CORRECTLY WITH THE REPLACEMENT CATHETER. INVESTIGATION OF THE CATHETER WAS LIMITED TO NON-DESTRUCTIVE TESTING AT THE DIRECTION OF THE USER FACILITY. THE ULTRASOUND CORE OPERATED NORMALLY DURING TESTING. THE DRUG DELIVERY CATHETER WAS NOT RECOGNIZED BY THE INSTRUMENT DUE TO A BROKEN PIN OR WIRE, HOWEVER, BECAUSE THE CONNECTOR COULD NOT BE DISASSEMBLED, THE EXACT CAUSE COULD NOT BE DETERMINED. EKOS DOES NOT CONSIDER THIS A REPORTABLE EVENT. EVAL: THE LOG FILE IN THE CONTROL UNIT WAS AVAILABLE AND WAS REVIEWED. CONCLUSION: THE INVESTIGATION RESULTS DO NOT MATCH THE CUSTOMER'S REPORT. NO CONCLUSION CAN BE DRAWN.