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G4 ¿ pma/510(k) #: exempt investigation ¿ evaluation reviews of the complaint history, device history record (dhr), instructions for use (ifu), manufacturer¿s instructions (mi), and quality control (qc) procedures were conducted during the investigation.Functional tests and visual inspection of the returned complaint device were also conducted.One urostream hydrophilic wire guide was returned for investigation in a product protector.The protector was filled with water and the guide was removed.Entire length was sufficiently coated.A section of guide wire coating approximately 10 cm long is damaged, starting 15 cm from flexible tip.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) found no related non-conformances reported for lot.A complaint history database search showed no other related complaints associated with the failure mode for the complaint device lot.Cook also reviewed product labeling; the ifu supplied with the device states the following in consideration of the reported failure mode: precuation end hole size and length of device must be taken into consideration to ensure a proper fit between the wire guide and the procedural device.Manipulation of the wire guide requires appropriate imaging control.Use caution not to force or overmanipulate the wire guide when gaining access.Warnings: the hydrophilic coating on the wire guide is activated by immersion in sterile water or sterile saline solution.Failure to cover the wire guide with solution may lead to difficulty and patient injury when the wire guide is advanced.Device preparation.1.Using aseptic technique, remove the wire guide dispenser with the wire guide from its outer packaging and place the wire guide dispenser with the wire guide in the sterile field.2.Prior to removing the hydrophilic wire guide from its dispenser, fill a syringe with sterile water or sterile saline solution and inject the solution into the luer lock hub at the end of the dispenser.3.Inject enough solution to fill the dispenser coil.The solution will completely cover the wire guide surface and activate the hydrophilic coating.(see fig 1.) 4.Remove the hydrophilic wire guide from its dispenser by gently withdrawing the wire guide via its tip.Note: if the hydrophilic wire guide cannot easily be removed from its dispenser, then inject more solution into the dispenser and attempt withdrawal again.Instructions for use: 1.Flush the procedural device with saline solution before and during use to ensure smooth movement of the hydrophilic wire guide within the device.2.Advance the flexible end of the wire guide into the procedural device and position the wire guide in the desired anatomical location.Note: for optimal performance, rehydrate the hydrophilic-coated wire guide after exposure to ambient environments or if the lubricity of the wire guide is diminished.Replace the wire guide with a new hydrophilic-coated wire guide if wire guide lubricity remains diminished.3.After wire guide use is complete, remove the wire guide from the patient and discard the wire guide in an appropriate waste receptacle.The doctor who reported the complaint indicate the damage might be due to the scope.Based upon the available information, inspection of the returned device, and results of the investigation, cook has concluded that the cause for the complaint could not be established.It's not possible to rule out the scope used with the wire guide as contributing to the complaint.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the 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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It was reported prior to a retrograde intrarenal surgery (rirs), a urostream hydrophilic wire guide felt sluggish and got stuck during insertion into the scope.Prior to insertion, the wire guide was hydrated and kept wet when not in use.Reportedly, the wire felt "torn up, spiky".The physician reported it might be due to the scope.The device did not make patient contact.The patient did not require any additional intervention due to this occurrence.The patient did not experience any adverse effects due to this occurrence.
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