As the device was received in a condition was contradictory to the complaint description (pushwire found broke).This condition was not reported at the time of the event.As received, the pipeline flex braid with delivery system was found partially deployed and protruding from within marksman distal tip.The pipeline flex braid distal end was found fully opened and damaged (frayed).The pipeline flex proximal and distal dps restraints and sleeves were found intact; however, the tip coil was found damaged.The pipeline flex braid with delivery system was pulled out from within the marksman distal tip with resistance.The re-sheathing marker was found intact; however, the re-sheathing pad, proximal pad restraint, and proximal bumper were found dislodged.The pushwire was found detached at the distal hypotube weld (solder joint).The dislodged re-sheathing pad and proximal pad restraint were found within the braid proximal end.The pipeline flex braid proximal end was found in good condition.The pusher was found separated at the distal hypotube proximal to the bumper.There was evidence of corrosion around the broken end.The remaining portion of the pusher was found missing and not returned.The ends of the detached pushwire and the separated hypotube were sent out for sem (scanning electron micrographic) / eds (energy dispersive spectroscopy) elemental analysis.The elemental analysis of the detached pushwire end showed presence of tin (sn).Regarding the separated hypotube, the analysis states that no original fracture features are visible on the fracture surface.We were unable to determined the cause of the event.Separation can occur if excessive force is used exceeding the tensile strength of the material.Regarding the solder joint separation issue, in addition to excessive force, separation can occur due to inadequate solder/tinning.As the analysis showed presence of soldering material (tin); thereby indicating that the soldering was conducted.If information is provided in the future, a supplemental report will be issued.
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Medtronic received information that all pipeline flex was stuck inside the marksman catheter.The patient underwent embolization treatment for a small unruptured saccular posterior communicating aneurysm, measuring 5.67mmx10.1mm.Landing zone distal 2.88mm proximal 3.21mm.The vessel was normal tortuous.It was reported that during the operation, pipeline could not be pushed out from marksman.Many attempts were still not possible.No patient injury was reported.Evaluation of the returned device found that the pushwire was found detached at the distal hypotube weld (solder joint).
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