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As reported, during a peripheral transluminal angioplasty, the coating of a roadrunner uniglide hydrophilic wire guide peeled from the inner mandril of the device.The device was activated using saline before use.Access was gained without complication from the left side for crossover treatment, and a sheath was placed in the right external iliac over the wire guide.Significant stenosis and a 2-3cm occlusion in the p1 and p2 popliteal artery, respectively, were noted, as well as a floating thrombus in the joint gap.As the wire guide was attempted to be removed through another manufacturer's catheter, the wire became stuck in the catheter.The wire was able to be removed with difficulty.Another wire guide was placed to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Upon return evaluation of the device, 2mm of the inner wire was exposed.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Event summary as reported, during a peripheral transluminal angioplasty, the coating of a roadrunner uniglide hydrophilic wire guide peeled from the inner mandril of the device.The device was activated using saline before use.Access was gained without complication from the left side for crossover treatment, and a sheath was placed in the right external iliac over the wire guide.Significant stenosis and a 2-3cm occlusion in the p1 and p2 popliteal artery, respectively, were noted, as well as a floating thrombus in the joint gap.As the wire guide was attempted to be removed through another manufacturer's catheter, the wire became stuck in the catheter.The wire was able to be removed with difficulty.Another wire guide was placed to complete the procedure.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Upon return evaluation of the device, 2mm of the inner wire was exposed.Investigation - evaluation reviews of the complaint history, device history record, instructions for use, manufacturing instructions, and quality control procedures and a visual inspection of the device were conducted during the investigation.One roadrunner uniglide hydrophilic wire guide (hpwas-35-260) was returned to cook for investigation.The coating was reactivated with water, and the wire guide felt lubricious.The device length measured within specification.2mm of the inner wire was exposed.The outer black sheath was damaged.A document-based investigation evaluation was performed.No related non-conformance's were recorded, and there have been no other reported complaints for this lot number.The device history record review provides objective evidence that the device was manufactured to specification.There is no evidence of nonconforming devices from the complaint lot in house or in the field.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was functionally inspected by quality control and no notable gaps in production or processing controls were noted.There is no indication that a design or process related failure mode contributed to the reported event.Sufficient inspection activities are in place to identify this failure mode prior to distribution.The device is provided instructions for use which provide the following instructions for preparation and use of the device: preparation 1.Before removing the hydrophilic wire guide from its dispenser, inject sterile heparinized saline solution into the luer lock hub end of the dispenser.2.Inject enough solution to fill the dispenser coil.This will completely cover the wire guide surface and activate the hydrophilic coating.3.Remove the hydrophilic wire guide from its dispenser by gently withdrawing the wire¿s tip.4.If the hydrophilic wire guide cannot easily be removed from its dispenser, inject more heparinized saline solution into the dispenser and then try again.Wire guide use 1.Fill catheter or other device with heparinized saline solution before and during use to ensure smooth movement of the hydrophilic wire guide within the device.2.When wet with saline solution or blood, the hydrophilic wire guide will become lubricious.Use of sterilized gauze moistened with heparinized saline solution facilitates handling the wire.3.Insert the wire guide into the device and advance to desired position.Note: if movement of the wire within the device becomes diminished, remove the wire guide and reactivate the hydrophilic coating by wetting its entire surface with heparinized saline solution.Based on the available information, cook has concluded that the patient¿s occluded and stenosed anatomy and floating thrombus in the joint gap contributed to this event.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.Per the quality engineering risk assessment, no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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