Medtronic received information regarding a pipeline device that was unable to be deployed completely and could not be resheathed after partial deployment.It was reported that an attempt was made to implant the pipeline.However, after the tip of the stent deployed a little, both insertion and removal of the stent could not be completed.It was suspected at the pushwire may have fractured.Because just a small portion of the device had been deployed, the pipeline was removed along with the phenom-27 microcatheter and the devices were replaced.The patient did not sustain any harm or injury during the procedure.
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Product analysis #703710350:equipment used: video inspection system (m-77148), ruler (m-83360), camera (panasonic lumix dmc-zs5); 0.0260¿ mandrel the pipeline flex w/ shield pushwire (pli-10) (model: ped2-500-18 lot: a846930) was returned for evaluation within a shipping box; within a resealable plastic biohazard pouch; within a second resealable plastic pouch and without a dispenser coil.The device was decontaminated.The pushwire was found separated at ~106.8cm from the proximal end with the ptfe shrink tubing broken at the same location.The separation location was where the proximal corewire met the hypotube.No other damages were found with the pushwire.The distal and proximal dps restraints were found to be intact.The dps sleeves were found intact with no signs of damage.The distal hypotube was found to be intact with no signs of elongation.No defects were found with the tip coil, distal marker, re-sheathing marker, re-sheathing pad or with the proximal bumper.Dried blood was found throughout the braid and distal pushwire.The braid did not fully open on both ends(hourglass).The braid was put into an ultrasonic cleaner to dissolve the dried blood.The braid fully opened on both ends; however, the distal end was found severely damaged/frayed.No other anomalies were observed.The broken end will be sent out for sem/eds analysis.The customer report of ¿resistance/stuck during delivery,¿ ¿resistance during re-sheathing/failure to resheath¿ and ¿device to device entanglement¿ were confirmed as the pipeline flex w/ shield was found stuck within the micro catheter.It is possible that the braid became damaged and caused the resistance and entanglement.Other possible causes are patient vessel tortuosity, user does not maintain continuous flush, user pulls back on/torques wire while advancing ped in micro catheter.The cause of the braid damage could not be determined.Customer reported patient vessel tortuosity as moderate.Based on the returned device, the pipeline flex was confirmed to have ¿pushwire break/separation¿ issue.Per the sem/eds results: "fatigue features (striations) were observed, indicating the crack initiated via fatigue.The final crack area failed via tensile overload.Lack of fusion is visible at weld root areas." it is possible that the lack of fusion at weld root area and the attempt the retract the device against the reported resistance caused the pushwire to separate.The review of lot history records shows that the finished device has met all manufacturing requirements and specifications during final assembly and quality inspection.Review of proximal delivery system subassembly documentation (p/n 50648-001 lot 796064) found no discrepancies for dimension iqc14: proximal and distal weld inspection.Certificate of conformance (resonetics llc) shows tensile strength of wire to hypotube strength between 75.5n to 89.9n, which is within specification.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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