As found condition: the axium prime pushwire was returned for analysis within a shipping box; and within a plastic bio- pouch.¿visual inspection/damage location details: the axium prime pushwire was returned within the introducer sheath.The introducer sheath was found correctly assembled on the pushwire with the wavelock at the proximal end.The axium prime pushwire was found to be bent at ~21.0cm from proximal end.In addition, the axium prime pushwire was appeared to be bent within introducer sheath at ~109.3cm from proximal end.The axium prime implant coil was found to be to be broken and detached from the detach element and not returned for analysis.Therefore, device analysis could not be performed and conformance to specifications could not be assessed.No damages or irregularities were found with the introducer sheath.No other anomalies were observed.¿testing/analysis: the axium prime pushwire could not be pushed out from the introducer sheath as it was appeared to be stuck.¿conclusion: based on the device analysis and the reported information, the customer¿s report of ¿coil resistance/stuck in sheath¿ was confirmed.It is likely the axium prime implant coil became damaged upon pushing out from within the introducer sheath for preparation subsequently becoming stuck; however, the root cause for the damage could not be determined.Regarding the damage to the pushwire, damage is likely to occur if the user advances the coil against resistance.There was no non-conformance to specifications identified that led to the resistance issue.If information is provided in the future, a supplemental report will be issued.
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