Six radiographic images are supplied in place of a returned product.The images show the distal web is expanded in the distal part of the aneurysm.The proximal part (not detached) is collapsed and protrudes into the basilar tip.The images do not identify the cause for this event.Without the return and physical evaluation of the device, the investigation cannot determine if a condition exists that would have caused on contributed to the reported event.Items returned: n/a.Visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: a search for non-conformances associated with this part/lot number combination could not be performed as this information was not available at the time this investigation was performed.Ifu review (additional information can be found in the ifu): potential complications potential complications include but are not limited to the following: vessel puncture site hematoma, aneurysm perforation or rupture, hemorrhage, edema, thromboemboli, transient ischemic attack, ischemic stroke, neurologic deficits, parent artery occlusion, ischemia, vessel dissection or perforation, vascular thrombosis, vasospasm, device migration or misplacement, premature detachment, headache, post-embolization syndrome, infection and death.The web embolization device requires the use of fluoroscopy.Potential complications related to angiographic and fluoroscopic radiation doses include, but are not limited to, alopecia, burns ranging in severity from skin reddening to ulcers, cataracts, and delayed neoplasia.The probability of occurrence of complications may increase as procedure time and number of procedures increase.Other procedural complications including but not limited to anesthetic and contrast media risks, hypotension, hypertension and access site complications.Warnings: do not rotate the delivery device during or after delivery of the web embolization device.Rotating the web embolization device may result in damage or premature detachment.Procedure - instructions for use detachment of the web embolization device 34.The detachment control device is pre-loaded with batteries and will activate when the delivery device is properly connected.35.Verify that the rhv is firmly locked around the delivery device before attaching the detachment control device to ensure that the web embolization device does not move during the connection process.36.Ensure that the delivery device gold connectors are clean and free from blood or contrast.If necessary, wipe the connectors with sterile water and dry before connecting.37.Insert the proximal end of the delivery device into the detachment control device.When the delivery device is properly connected, the light will flash green and an intermittent tone will be heard.38.Verify the web embolization device position before pressing the detachment button.39.Push the detachment button.During firing, the light should be solid green and the beep should be continuous.40.Verify detachment by first loosening the rhv valve, then pulling back slowly on the delivery device and verifying that there is not web embolization device movement.If the web embolization device does not detach, push the detachment button again.If the web embolization device is still not detached, obtain a new detachment control device and attempt detachment up to two additional times.If it does not detach, remove the delivery device.41.Verify the position of the web embolization device angiographically through the guide catheter.42.Prior to removing the microcatheter from the treatment site, place an appropriately sized guidewire completely through the microcatheter lumen to ensure that no part of the web embolization device remains within the microcatheter.The physician has the discretion to modify the web embolization device deployment technique based on the complexity and variation in embolization procedures.Any modifications must be consistent with the previously described procedures, warnings, precautions and patient safety information in these instructions for use.
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