This is a report for a similar device that is not marketed in the us.Suspect medical device - similar device brand name = pipeline flex w/shield technology model # = ped2-500-20 as the device was received in a condition was contradictory to the complaint description.The pipeline flex device pushwire found broken.This condition was not reported at time of the event.It was also reported that no patient involved in this event.The follow up attempted to find out event detail; however, the hcp was not willing to provide any information.As received, the pipeline flex braid was returned detached from the pushwire.The pushwire was returned within its introducer sheath.No bends or kinks were found with the pipeline flex pushwire.The pipeline flex pushwire was pushed out from within the introducer sheath without issue.The ptfe shrink tubing was intact but pulled back from the proximal bumper.The pipeline flex distal hypotube was not found stretched.The proximal bumper, re-sheathing pad and re-sheathing marker were found intact.The pipeline flex pushwire was found separated proximal to the dps restraints/sleeves.The pipeline flex dps restraints/sleeves were returned; however, the tip coil was not returned and the reason for not returning was not provided.The pipeline flex braid was examined.As the pipeline flex braid was returned detached from the pushwire, the distal and proximal ends of the braid were unable to be identified.One braid end was found damaged (frayed) and not fully open.The other braid end was found in good condition.The pipeline flex pushwire was sent out for sem (scanning electron micrographic) failure analysis.Per the analysis report, elevated iron (fe), chromium (cr), and oxygen (o) peaks were detected on the fracture surface.The wire end was completely corroded.No original fracture features are available.Based on the device analysis and sem result, we were unable to determined the cause of the event.Based on the formal investigation conducted, pushwire separation can occur due to certain use conditions such as excessive force and patient vessel tortuosity.If information is provided in the future, a supplemental report will be issued.
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