The complaint reported by the customer as "stent delivery system (sds)-ses - withdrawal difficulty - snagged/caught on stent" was not confirmed since insertion/withdrawal test couldn't be performed on the unit due to the separation observed on the inner shaft.The complaint reported by the customer as "catheter tip - separated - in patient" was confirmed since a material separation was observed on the inner shaft near to the distal tip.Nevertheless, per microscopic analysis, scanning electron microscopy (sem) results showed that the separated area of the inner shaft of the unit presented evidence of elongations.Braid wires on the inner shaft presented evidence of plastic deformation, diameter reduction, tension marks and ductile dimples on their surface.The previously mentioned damages are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the inner shaft material was induced to a tensile force that exceeded the inner shaft material yield strength prior to the separation.Per the observed damage, it could be suggested that procedural factors and/ or handling process may have contributed to the observed damaged condition of the unit.Nevertheless, the cause of the material separation observed on the inner shaft could not be conclusively determined during the analysis.Neither the phr review nor the product analysis suggests that the reported failure could be related to the manufacturing process of the unit.
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It was reported that during a transcarotid artery revascularization (tcar) procedure, the sds distal tip became entangled in the stent when the physician attempted to remove it.The physician used various methods to free the device and was unsuccessful.Re-sheathing the tip, twisting, advancing then retracting, etc.The distal 5cm of the catheter became disconnected from the sds.The physician used a glidewire next to the existing interventional wire in place to deliver a 5x30 balloon.The balloon was inflated then removed and a 5mm snare was used to capture the fragment.It was successfully removed.
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