As the device was received in a condition was contradictory to the complaint description.The pipeline flex device the tip coil and distal wire was found separated from the hypotube at the distal hypotube weld (solder joint).This condition was not reported at time of the event.The pipeline flex and medtronic catheter were returned for analysis.The pushwire coil tip was pushed outside of the catheter tip.Resistance was encountered when attempting to advance or retract the braid out of the micro catheter.The braid was pushed out the distal end.The pushwire was retracked out of the hub of the catheter.No damages or irregularities were found with the pipeline flex pushwire; however, the tip coil and distal wire was found separated from the hypotube at the distal hypotube weld (solder joint).The hypotube appeared to be intact and with no stretching and the ptfe shrink tubing was found still intact.The distal and proximal braid sections did not fully open, and dried blood was found on the braid.The middle section of the braid was found fully opened.The distal wire was found stuck within the braid.The braid was put into cleaner to remove the dried blood.The proximal braid fully opened however the braid was found slightly tapered.The distal braid section fully opened; fraying and damages were observed with the braid tips.The pad assembly came off the distal wire due to the separation but was found intact.From the damages seen on the pipeline flex braid (frayed/damaged distal end) and pushwire (separation at solder joint); it appears there was high force used.It is likely these damages occurred when the customer attempted to advance and retract the pipeline flex through the marksman catheter against resistance.The end of the detached distal wire was 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).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 during procedure, the pipeline couldn't be pushed out from marksman normally.Replaced with a new one and the procedure completed normally.The patient underwent embolization treatment for an aneurysm.The vessel tortuosity was normal.There were not any patient symptoms or complications associated with this event.No patient injury was reported.Reported device and any accessory devices were prepared as indicated in the ifu.The catheter flushed as indicated in the ifu.Evaluation of the returned device found that the pipeline flex pushwire, tip coil and distal wire was found separated from the hypotube at the distal hypotube weld (solder joint).
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