The device has not been returned for evaluation; therefore, the event cause could not be determined.Correspondence has been received stating that the device has been sent back.Once the device has been received and evaluated, a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.
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The pipeline flex delivery system and the catheter used in the event were returned for evaluation and the tip coil and the sleeves appeared to be stuck outside of the catheter tip.The remaining segment of the pushwire was found within the catheter lumen.For further examination, the pipeline flex delivery system was then pushed out from the catheter lumen with difficulty.The pipeline was examined and the distal hypotube appeared to be stretched with the ptfe shrink tubing still intact.The pipeline braid was found fully opened with no damage.The pushwire was found to be bent near the proximal end.No other defects were found with the pipeline.The phenom 27 microcatheter was examined and the body was found to be accordion near the distal tip.The catheter was flushed with water and found to be patent.The catheter was then tested by running an in-house mandrel through catheter tip and hub and it was able to pass through the catheter tip and hub; however, resistance was observed at the accordion location.No other anomalies were observed.Based on the analysis findings and the event descriptions, the customer reports of ¿resistance during delivery¿, ¿failure to resheath¿ and ¿catheter resistance¿ were confirmed as the tip coil and sleeves of the returned pipeline flex were found to be stuck outside of the catheter tip.In regards to ¿failure to open at the distal end and middle section¿ issues, the customer complaint could not be confirmed as the returned pipeline flex braid was found fully opened with no damage.The returned pipeline flex and the phenom catheter were found to be damaged.The customer reported that the devices were prepared per the ifu and a continuous flush with heparinized saline was maintained during procedure.In addition, the patient¿s vessel tortuosity was severe.It is possible that the ¿severe vessel tortuosity¿ may have contributed to the reported resistance.From the damages seen on the catheter body (accordioning), proximal wire (kinking/bending) and hypotube (stretching); it appears there was high force used (pushing and pulling).It is likely these damages occurred when the customer attempted to advance/retrieve the pipeline flex delivery system through the phenom catheter against resistance.Per our instructions for use (ifu): ¿begin to deliver the device using a combination of unsheathing the pipeline flex embolization device and pushing delivery wire simultaneously.After the distal end of the pipeline flex embolization device has successfully expanded, deploy the remainder of pipeline flex embolization device by pushing the delivery wire and/or unsheathing the pipeline flex embolization device.Resheathing and/or manipulation of the micro catheter, by locking down the delivery wire and moving both as a system, may facilitate expansion of the pipeline flex embolization device.Carefully inspect the deployed pipeline flex embolization device with shield technology under fluoroscopy to confirm that it is completely apposed to the vessel wall and not kinked.If the device is not fully apposed or is kinked, consider using a balloon catheter, micro catheter, or guide-wire to fully open it.Discontinue delivery of the device if high force or excessive friction is encountered during delivery.Identify the cause of the resistance and remove device and microcatheter simultaneously.Advancement of the ped against resistance may result in device damage or patient injury.Never advance or withdraw an intraluminal device against resistance until the cause of resistance is determined by fluoroscopy.If the cause cannot be determined, withdraw the catheter.Movement of the micro catheter against resistance may result in damage to the micro catheter, or the vessel.Do not use in patients in whom the angiography demonstrates the anatomy is not appropriate for endovascular treatment, due to conditions such as severe intracranial vessel tortuosity or stenosis.¿ no evidence was found to suggest that the devices failed to meet specifications; therefore, manufacturing has been ruled out as a potential cause.All products are 100% inspected for damage and irregularities during manufacture.If information is provided in the future, a supplemental report will be issued.
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