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As reported, the patient was admitted on (b)(6) 2023 with diagnosis of bilateral upper ureteral calculus with hydronephrosis.On (b)(6) 2023, during transurethral ureteral pneumatic lithotripsy a stent was placed.While advancing the stent through a hiwire nitinol hydrophilic wire guide to the ureter, resistance was felt between the wire guide and the stent pusher, causing the inner wire of the wire guide to extrude out.Another same wire guide was used to complete the procedure.The user facility believes the issue may of been caused by insufficient lubrication of the wire guide with water.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.No adverse effects to the patient were reported.
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Event summary: as reported, the patient was admitted on (b)(6) 2023 with diagnosis of bilateral upper ureteral calculus with hydronephrosis.On (b)(6) 2023, during transurethral ureteral pneumatic lithotripsy a stent was placed.While advancing the stent through a hiwire nitinol hydrophilic wire guide to the ureter, resistance was felt between the wire guide and the stent pusher, causing the inner wire of the wire guide to extrude out.The wire guide was lubricated initially and during the procedure with saline.The coating was activated for 1 minute.Another same wire guide was used to complete the procedure.The user facility believes the issue may of been caused by insufficient lubrication of the wire guide with water.No section of the device remained inside the patient's body.The patient did not require any additional procedures due to this occurrence.No adverse effects to the patient were reported.Investigation ¿ evaluation: a document based investigation was performed including a review of complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, were conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document-based investigation evaluation was performed.No related non-conformances were recorded.A review of the complaint history found one additional complaint for the lot for the same reported failure mode.As the supplier investigation concluded the additional complaint was not caused by manufacturing cook has concluded the complaints are unrelated.The evidence from the complaint file, device history record, complaint history and quality control documents indicates that the complaint device was manufactured to specification as well as other items in the lot or similar devices in the field or in house.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 wire guide was supplied with ifu which includes the following: 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.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 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.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.Based on the available information, cook has concluded the cause for the complaint cannot be established; it was not possible to rule out procedural factors.The user facility conducted a preliminary analysis of the compliant and provided a potential cause "wire guide probably was not completely lubricated by water.", however no additional details could be provided about how this conclusion was reached.Cook will continue monitoring of similar complaints and has notified the appropriate personnel of this event.¿ per a review of risk documentation, 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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