Update: h4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added d10 product available to stryker ¿ updated d10 returned to manufacturer on ¿updated the returned product was confirmed to be the product reported in the complaint.The lot number was confirmed with the packaging returned with the device.During visual inspection, it was noted the main coil was stretched and found manually detached.The coil delivery wire was not returned for analysis.Functional inspection was unable to be carried out as the main coil was detached, however the reported events confirmed during analysis are consistent with the event.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The edhr (electronic device history record) for each lot is created and maintained in mes (manufacturing execution system).Automated controls within the mes system ensure that all product is manufactured in accordance to the dmr (device master record).The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The event is anticipated and contained in the rmf.The device was returned for analysis and the reported defect was not confirmed however, the analysis results are consistent with the event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that intermittent flush was maintained.As per the dfu, ¿in order to achieve optimal performance of the target detachable coil system and to reduce the risk of thromboembolic complications, it is critical that a continuous infusion of appropriate flush solution be maintained between a) the femoral sheath and guiding catheter, b) the 2-tip microcatheter and guiding catheters, and c) the 2-tip microcatheter and stryker neurovascular guidewire and delivery wire.Continuous flush also reduces the potential for thrombus formation on, and crystallization of infusate around, the detachment zone of the target detachable coil.¿ it is probable that insufficient flush caused the reported defect.Based on the investigation results and available information an assignable cause of user error will be assigned to as reported events.
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