Description of event according to initial reporter: when the physician was advancing the filter catheter with the protection sheath combined through the sheath, he pushed the safety button by mistake.However, he thought that the filter would not be released unless the release button was pushed, so he continued the procedure with the safety button unlocked.When he withdrew the introducer sheath and protection sheath to deploy the filter, the filter became detached unexpectedly without pushing the release button.The released filter was retrieved from the patient.Though it was considered to re-attach the filter to the delivery system for another try, but the device set was replaced with another igtcfs-65-1-jug-tulip set to avoid any risk.Patient outcome: there have been no adverse effects to the patient reported.
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Manufacturer ref# (b)(4).Summary of investigational findings: it was reported that while advancing the jugular filter introducer through the introducer sheath the physician pushed the red safety button by a mistake.The physician thought that the filter would not be released unless the release button was pushed, so the physician decided to continue the procedure regardless the red safety button had been pressed down and the release button unlocked.When the physician withdrew the introducer sheath and protection sheath to deploy the filter, the filter became detached unexpectedly without pushing the release button.The released filter was retrieved from the patient.It was considered to re-attach the filter to the delivery system for another try, but the device was replaced with another device to avoid any risk.The procedure was completed with the replacement and there have been no adverse effects to the patient reported.Jugular introducer and introducer sheath was returned for device evaluation.It was observed that the safety button was not pressed down on the jugular introducer i.E., the system was locked.It was not possible to push the release button down on the locked system.After the safety button and the release button had been pressed down it was possible to get the grasping hook out.The grasping hook was then cleaned and observed to had been pulled long.A test filter was used in attempt to see if a filter could be attached to the jugular introducer.It was possible to attach a filter to the jugular introducer, but the filter hook was not fully covered by the grasping hook.The handle was then separated to see if the filter had been released during the system was locked but there was no indication that the filter had been released in locked condition.No nonconformances were observed on the introducer sheath.The cause for the reported failure cannot be determined based on the device evaluation.It was assessed that because no non-conformances were detected, there is evidence that the dhr was fully executed.In addition, no other lot related complaints have been received from the field.It is therefore concluded that there is no evidence that nonconforming product exists in house or in field.According to the instruction for use if the filter is not in the desired position, carefully advance the introducer sheath over the filter until right before the anchors.Reposition the system as desired, and again withdraw the introducer sheath and protection sheath until the protection sheath and jugular introducer handle are in contact with one another, completely exposing the filter.There are adequate controls in place to ensure the device was manufactured to specifications.Based on the provided information an exact cause for this event cannot be established.It is unknown why it is reported that the safety button had been pushed down and on the returned jugular introducer the safety button had not been pressed down.But during device evaluation it was observed that the grasping hook had been pulled long.This could had happened if the jugular introducer was pulled back in attempt to repositioning the filter and resulted in the unexpected filter release, but this is purely speculations.Cook medical will continue to monitor for similar events.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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