ASCENDA

Additional Manufacturer Narrative

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem

INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A CATHETER USED WITH AN IMPLANTED INFUSION PUMP. PER THE HCP, THE CATHETER WAS NOT USED AS IT BROKE DURING THE PROCEDURE AND IT WAS DISCARDED IN THE OR (OPERATING ROOM). THE HCP COULD NOT REMEMBER THE DATE OF THE EVENT OR MANY DETAILS, BUT NOTED THAT THEY DIDN'T THINK THERE WAS A DEFECT WITH THE CATHETER. THE HCP THOUGHT IT WAS THE PATIENT'S ANATOMY AS THE PATIENT WAS A CHILD. THE MANUFACTURER REPRESENTATIVE PRESENT AT THE CASE FURTHER NOTED THAT THE PHYSICIAN DAMAGED BOTH CATHETERS BY BENDING THEM BEFORE IMPLANTING THEM IN THE PATIENT. THE ACCOUNT REPORTEDLY FELT IT WAS USER ERROR SO THE CATHETER WAS NOT RETURNED. THE DEVICE WAS NEVER IMPLANTED, SO NO ADDITIONAL TUNNELING WAS REQUIRED. THERE WAS NO IMPACT TO THE PATIENT AND THE DEVICE WASN'T USED FURTHER. IT WAS SPECIFIED THAT THE IMPLANT WAS SUCCESSFUL. NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.