It has been reported that the guidewire had been broken and a 10cm section of the guidewire remained inside the patient.A provide picture showed a uncoiled guidewire.After several failed attempts to send the device for evaluation, a retained sample was investigated visually.The retained sample of the same lot (722789) was visually analyzed.No deviation could be detected.A dhr review did not reveal any non conformity or deviation from specification which could have contributed to the event.There is no indication for a systematic root cause as a deficiency of design, production or material considering the very low complaint rate (b)(4) , considering all types of picco catheters).One similar complaint has been received, reporting a guidewire separation and remaining parts in the patient.Unfortunately, the product in question was not available for analysis.Therefore, it is not possible to determine whether the device has failed to meet its specifications when the event occurred.Considering worst case scenario, a relationship between the device and the complaint is therefore considered as likely.Information indicates that upon the complaint occurrence the device was involved and used on a patient for advanced hemodynamic monitoring.Upon the event occurrence the device was involved and catheter insertion procedure on a patient for advanced hemodynamic monitoring was ongoing.The accessory guidewire is supplied in the product picco catheter.The procedure to insert a catheter (¿seldinger technique¿) is well known for healthcare professionals.The issue is monitored on a regularly basis in order to detect early trends.As there is no trend for this kind of issue no additional actions will be taken.With the information stated above the complaint will be closed.Correction: of udi from (b)(4) to (b)(4).H3 other text : device requested but not returned.
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