As reported by a healthcare professional, during the coil embolization, the orbit helical fill coil (637hf0206/17360454) could not be detached.They withdrew the coil and used a new coil to complete the procedure using the same unspecified syringe.Prior to attempt to detach, it was verified under fluoro that there was no stress against the microcatheter or delivery tube.Neither the coil nor the delivery system appeared damaged during the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis; however, the syringe was discarded.
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As reported by a healthcare professional, during the coil embolization, the orbit helical fill coil (637hf0206/17360454) could not be detached.They withdrew the coil and used a new coil to complete the procedure using the same unspecified syringe.Prior to attempt to detach, it was verified under fluoro that there was no stress against the microcatheter or delivery tube.Neither the coil nor the delivery system appeared damaged during the procedure.There was no report of patient injury.It was reported that the device would be returned for analysis; however, the syringe was discarded.A non-sterile orbit helical fill 2x6 was received coiled inside of a plastic bag.The hub, the hypo tube and introducer were inspected and no damages were noted.The support coil, gripper and embolic coil were found outside of the introducer.The gripper and embolic coil were inspected under microscope; no damages were noted on the gripper while the embolic coil was found stretched in tangled condition.Using a lab sample syringe, the orbit device was purging on the blue zone.The pressure gauge was increased to the green zone and the embolic coil was detached without any difficulty.A review of the manufacturing documentation associated with this lot 17360454 presented no issues during the manufacturing process that can be related to the reported complaint.The detachment failure was not confirmed during the functional test.The cause of the stretched condition found on the embolic coil was apparently caused by applying excessive force on the device but it could not be conclusively determined.However, this defect could not be related to the manufacturing process and procedural factors appear to have contributed to have this damage.It was reported that the device did not appear damaged during the procedure, and the device was returned entangled; therefore, the coil stretch was related to post-procedure handling.Devices are inspected for this type of damage prior to being released for distribution.Neither the analysis nor the dhr suggest that the failure reported could be related to the manufacturing process therefore, no corrective action will be taken at this time.
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