Two pictures of the guidewire have been provided.The picture showed an uncoiled wire.The hospital indicated that the guidewire is complete ("yes, the sister, doctor and nurse in charge all examined the wire following removal and felt that the line was intact and none had been left in the patient.") a dhr review did not reveal any non-conformities relevant to the reported issue.No further complaints have been received for this batch.According to specification the guidewire shall withstand a tensile strength of 10 n and a 100% control is performed during production.The complained guidewire has not been returned as it was discarded by the hospital.Therefore it is not possible to determine if the used catheter had any malfunction or any deviation from the specification that could have contributed to the incident.A retain sample of the same batch has been inspected, but no deficiency could be detected.Based on the provided information, investigations and experience the most probable root cause is seen in a handling error by the user.The ifu indicates:"warning: if resistance is encountered when removing the guide wire, the guide wire could be kinked about tip of catheter within vessel (fig.K).In this case withdraw the catheter by 2 to 3 cm and try again to remove the guide wire.Use of excessive force may tear off the guidewire.Therefore, guide wire and catheter are to be removed simultaneously.¿ additionally, a correct insertion angle (< 45°) of the cannula ensure that the guidewire can be advanced and removed without difficulty.Instructions for proper handling of the cannula and guidewire is provided in the instructions for use: "caution: make sure that the introducer cannula is introduced in a flat angle (less than 45°)." and "warning: do not withdraw guide wire against needle bevel to avoid possible severing or damage of guide wire." overall, investigations did not indicate that the device failed to meet its specification when the event occurred.But the complained product has not been returned to fully confirm this assessment.There is no indication for a systematic root cause as a deficiency of design, production or material considering the very low complaint rate (< 0,01 %, considering all types of picco catheters).Upon the event occurrence the device was involved and used on a patient for advanced hemodynamic monitoring.The accessory guidewire is supplied in the product picco catheter and is state of the art.The procedure to insert a catheter (¿seldinger technique¿) is state of the art for the 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.The report is considered as combined initial and final report.
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