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It was reported that prior to the beginning of a ureteroscopy, the hiwire nitinol hydrophilic wire guide was found to be "dry and not slippery".The operator thought the coating was separating from the guidewire at "first contact." it is unknown how the procedure was completed.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.Additional information has been requested and a follow-up report will be submitted when and if that information is received.
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Additional information: a1.Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, the instructions for use, specifications, and quality control data.The complainant returned 280 unused devices for investigation.Visual examination confirmed the wire guides were received in original sealed packages in unused condition.One sample of this lot number was opened to perform a physical examination.The coil was hydrated with water to remove wire from holder.The wire lubricity was sufficient and no anomalies were found on the wire.The supplier was contacted, and the supplier declined cook¿s request to returned unused sample for investigation.Supplier investigation conclusion: the clinically used complaint specimen was not available at the time of this report.Without the return of the actual device in question for evaluation, the supplier was unable to determine the exact cause for this incident.A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested at the supplier and was determined to be acceptable.The hydrophilic coating on this product is a transparent polymer coating that does expand when hydrated; however, any pressure (point or broad surface) on the hydrated coating will immediately displace the hydrating fluid in accordance to the amount of pressure applied.The complaint is unconfirmed as the clinically used complaint specimen was not returned for evaluation.At this time, it is not possible to assign a definitive root cause for the event as reported.A review of the device history record found no non-conformances related to the reported failure mode.A review of complaint history records shows no other complaints associated with the complaint device lot.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other related complaints from the lot have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: precautions: manipulation of wire guide requires appropriate imaging control.Use caution not to force or over manipulate the wire guides when gaining access.When using wire guide through a metal cannula /needle, use caution as damage may occur to outer coating.When exchanging or withdrawing an instrument over the wire guide, secure and maintain the wire guide in place under fluoroscopy in order to avoid unexpected wire guide displacement.These wire guides are not intended for tpca use.Instructions for activating hydrophilic coating: the hydrophilic coating on the wire guide is activated by immersion in sterile water or sterile saline solution.1.Prior to using the wire guide, fill a syringe with sterile water or sterile saline solution and attach it to the flushing port on the wire guide.2.Inject enough solution to wet the wire guide surface entirely.This will activate the hydrophilic coating.Hydrophilic coated wires are very slippery when wet.Always maintain control of the wire guide when manipulating it through any device.For optimal performance, rehydrate the hydrophilic coated wire guide after exposure to ambient environment or after extended use, replace it with a new hydrophilic coated wire guide.The unused wire guides were returned for a manufacturer's evaluation, however these devices are supplied to cook and the supplier will not evaluate unused wire guides per their management directive.While there is no evidence to suggest the device was manufactured out of specifications, this lot is associated with devices that were coated at the supplier with a chemical parameter that was on the low end of specification.Per the quality engineering risk assessment, no further action is warranted.Cook medical will continue to monitor this device via the complaints database for similar complaints.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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