Complaint conclusion: during an internal carotid artery stenting procedure, the angioguard (rx/5mm basket diameter/180cm) was removed from the packaging and flushed.The device was passed through the guiding catheter to the right common carotid artery; however, the device failed to go through the lesion after many tries.There was no reported patient injury.A 0.014¿ guidewire was used to go through the lesion and a 2.0mm x 15mm balloon was used for pre-dilatation.After the balloon was withdrawn, the guide catheter was used to advance the device through the lesion.After going through the lesion, the device system¿s outer sheath felt very tight and, after trying many times, could not release the device.The device was then replaced with another unknown device to complete the procedure.The lesion is the internal carotid artery which has a long segment total occlusion.The act was maintained greater than 300 while the angioguard was being deployed.There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.There were no kinks nor other damages noted prior to inserting the product into the patient.The product was prepped per the instructions for use (ifu).Upon opening the package, the deployment sheath tip was still fully seated in the filter basket introducer.The hemostatic valve was fully opened prior to insertion of the angioguard.The target lesion vessel diameter is 4.5mm.The angioguard was sized larger than the vessel as instructed in the ifu.There was no difficulty encountered when flushing the filter introducer and deployment sheath.Saline was noted within the coil dispenser at the green deployment sheath hub.The torque device was locked onto the guidewire.The anti-migration clip was located closest to the filter introducer and it was left in place until after the filter basket was docked into the deployment sheath.There was no difficulty experienced while docking the filter basket into the deployment sheath.The device passed through acute bends.The device did not have to pass through a previously placed stent.There was no difficulty accessing the lesion with a guidewire.Excessive torque was used during advancement or delivery of the angioguard.Sufficient space was allowed between the lesion and the filter basket to prevent interaction between devices.Both proximal and distal markers were positioned distal to the lesion being treated.The other devices used with the product did not kink nor bend at any time.No other information was reported.The device was returned for analysis.One non-sterile rx/5mm basket diameter/180cm along with a capture sheath was received for analysis inside a plastic bag.Neither coil nor deployment sheath or any other original packaging were returned.Per visual analysis, the angioguard was received inserted to the capture sheath.Per microscopic analysis, the unit was inspected under the fal vision system and the membrane of the angioguard was observed slightly smashed.Also, one of the joints of the device looked compressed/not distorted.The membrane of filter was observed separated/ uplifted from the basket wire and prolapsed.The tip of the platinum coil (floppy wire) was noted to be wavy and unraveled.No other anomalies were noted.Functional analysis could not be performed due to the mentioned concomitant delivery sheath not being returned for analysis.A device history record (dhr) review of lot 35232774 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿delivery system-deployment difficulty ¿ unable¿ was confirmed since the functional test to perform the deployment of the received filter basket could not be performed because the deployment sheath was not received.The reported ¿filter basket introducer-separated¿, ¿filter basket-damaged - in-patient", and ¿distal tip-unraveled/stretched¿ were also confirmed due to the damage conditions noted on the filter basket and on the coil tip of the device during microscopic analysis.The cause of the damaged conditions on the angioguard filter basket, filter basket introducer and on the coil tip could not be conclusively determined during the analysis.Based on the information available for review, vessel characteristics (total occlusion) as well as procedural factors (navigating acute bends and the application of excessive torque) may have contributed to the reported events.Per the ifu, which is not intended as a mitigation, ¿while gripping the torque device in one hand and the coil dispenser in the other, pull on the wire until the basket is completely docked into the tip of the deployment sheath.When completely docked, approximately half the filter basket will still be visible out the end of the deployment sheath.Remove the last anti-migration clip.Open the torque device.While gripping the torque device in one hand and the proximal end of the guidewire in the other, pull the wire through the torque device until the proximal end of the deployment sheath hub engages the torque nut.Lock the torque device onto the guidewire; ensure the deployment sheath hub remains engaged with the torque nut.Pull the wire and deployment sheath out of the dispenser coil.The deployment sheath is now prepped and ready for use.¿ ¿warning, if the wire tip becomes entrapped within the vasculature, do not torque the guidewire.Torqueing a guidewire against resistance may cause guidewire damage and/or guidewire tip separation.Always advance or withdraw the guidewire slowly.Never push, auger, withdraw or torque a guidewire, which meets resistance.Resistance may be felt and/or observed using fluoroscopy by noting any buckling of the guidewire tip.Determine the cause of resistance using fluoroscopy and take the necessary remedial action.¿ neither the product analysis nor the phr review suggests that the event could be related to the manufacturing process; therefore, no corrective action will be taken at this time.
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As reported, the angioguard (rx/5mm basket diameter/180cm) was removed from the packaging and flushed.The device was passed along the guiding catheter to the right common carotid artery; however, the device failed to go through the lesion after many tries.There was no reported patient injury.The product was clinically used and will be returned for analysis.A 0.014¿ guidewire was used to go through the lesion and a 2.0*15mm balloon was used to pre-expand.After the balloon was withdrawn, the guide catheter was used to advance the device through the lesion.After going through the lesion, the device system outer sheath felt very tight and, after trying many times, could not release the device system.The device was then replaced with another device system to complete the operation.The lesion is internal carotid artery for long segment total occlusion.The act maintained greater than 300 while the angioguard was deployed.There was no damage to the device noticed prior to opening the package.There was no difficulty removing the device from the sterile packaging.There were no kinks nor other damages noted prior to inserting the product into the patient.The product was prepped per the instructions for use (ifu).Upon opening the package, the deployment sheath tip was still fully seated in the filter basket introducer.The hemostatic valve was fully opened prior to insertion of the angioguard.The target lesion vessel diameter was 4.5mm.The angioguard was sized larger than the vessel as instructed in the ifu.There was no difficulty encountered flushing the filter introducer and deployment sheath.Saline was noted within the coil dispenser at the green deployment sheath hub.The torque device was locked onto the guidewire.The anti-migration clip was located closest to the filter introducer left in place until after the filter basket was docked into the deployment sheath.There was no difficulty experienced while docking the filter basket into the deployment sheath.The device passed through acute bends.The device did not have to pass through a previously placed stent.There was no difficulty accessing the lesion with a guidewire.Excessive torque was used during advancement or delivery of the angioguard.Sufficient space was allowed between the lesion and the filter basket to prevent interaction between devices.Both proximal and distal markers were positioned distal to the lesion being treated.The other devices used with the product did not kink nor bend at any time.Per fal analysis, during microscopic analysis, the unit was inspected and the membrane of the angioguard was observed slightly smashed.Also, one of the joints of the device looked compressed/not distorted, the membrane of filter was observed separated/uplifted from the basket wire and prolapsed/ folded over itself.The tip of the platinum coil (floppy wire) could be observed a little bit wavy and unraveled damage.
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