Procode: krd/hcg.(b)(6).Conclusion: a review of the manufacturing documentation associated with this lot 17318976 presented no issues during the manufacturing or inspection process that can be related to the reported complaint.The positioning and resheathing issues could not be confirmed without product return for analysis.The root cause of the event could not be determined; however, procedural/handling factors may have contributed to the failures.There is no current safety signal identified related to the reported events based on reviews of complaint histories for the devices.Since there was no evidence to suggest the event was related to a manufacturing issue, no corrective actions will be taken at this time.
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As reported by a healthcare professional, during coil embolization of a ruptured ic-pc aneurysm, an orbit galaxy ((b)(4)) was difficult to position and kicked back and could not be re-sheathed because the zipper became stuck, and orbit galaxy ((b)(4)) was out from the lesion, but did not protrude into the parent vessel and could not be re-sheathed because the zipper became stuck.It was not necessary to remove the microcatheter due to the events.The procedure was successfully completed without further issues or delay.There was also no patient injury / complication reported.The complaint product was new and stored per labeling instructions.The procedure was conducted in accordance with the ifu and the constant flush had been maintained at all time.No visible defect/damage was noted on the products prior to the event.No unintended detachment was observed in the vessel or in the microcatheter.The vessel was not tortuous or calcified.An sl 10 microcatheter was used for the procedure.The products are not available for investigation.No further information was available.
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