The event is reported at this time based on analysis results.Product analysis: the echelon-10 micro catheter was returned for analysis within a shipping box and within a sealed plastic biohazard pouch.The packaging was not returned for analysis.No flash or hub mold were found within the hub.No damages or irregularities were found with the echelon-10 hub.No damages were found along the echelon-10 micro catheter length.The distal tip and marker band were found separated from the echelon-10 micro catheter and not returned for analysis.The inner liner was found stretched, protruding out of the break.The echelon-10 total length was measured to be ~152.6cm and the useable length was measured to be ~144.8cm which is within specification (specification: total (ref) = 152cm; usable = 144cm ± 1.5cm).Based on the device analysis and reported information, the customer¿s report of ¿catheter kink/damage¿ was confirmed.The echelon-10 micro catheter distal marker band and distal tip were found separate.The investigation determined that this event was similar to an event that had already been investigated, and another investigation is not necessary.Based on the formal investigation, the failure mode was able to be re-created by p inching the tip protector in the wrong direction.This is caused by pinching the tip protector closed instead of pinching it open as the ifu and image on the packaging instructs.It was not possible to determine if the tip became damaged during packaging or while removing the catheter from the packaging.If information is provided in the future, a supplemental report will be issued.
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