MAUDE Adverse Event Report: COOK INC ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Model Number N/A

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/09/2023

Event Type  Injury  

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.E1: customer (person): phone = (b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.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.".

Event Description

As reported, during a percutaneous nephrolithotomy (pcnl) procedure, about 3 cm of coating from a 'roadrunner the firm hydrophilic wire guide' separated.The issue was discovered during removal of the wire guide.The coating was not removed during the procedure.Approximately 1 week after the pcnl procedure, the patient underwent a retrograde intrarenal surgery (rirs) procedure to remove the coating; however, no coating was found or retrieved during this procedure.The coating of the wire guide was activated with water.The wire guide was placed through a metal trocar cannula/needle; no other devices were used at the same time as the wire guide.No other adverse effects were reported for this incident.

Event Description

No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

Manufacturer Narrative

Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Correction: d10-concomitant products.Investigation ¿ evaluation.As reported, during a percutaneous nephrolithotomy (pcnl) procedure, about 3 cm of coating from a 'roadrunner the firm hydrophilic wire guide' separated.The issue was discovered during removal of the wire guide.The coating was not removed during the procedure.Approximately 1 week after the pcnl procedure, the patient underwent a retrograde intrarenal surgery (rirs) procedure to remove the coating; however, no coating was found or retrieved during this procedure.The coating of the wire guide was activated with water.The wire guide was placed through a metal trocar cannula/needle; no other devices were used at the same time as the wire guide.No other adverse effects were reported for this incident.Reviews of the 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 photo was received.Upon review, the ~3cm of coating is noted in the right kidney; the presumed wire guide is present in the right ureter.Additionally, a document-based investigation evaluation was performed.In response to this incident, cook completed a review of the product device master record (dmr) and concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Cook could not complete a review of the device history record (dhr) or search for other complaints from the product lot due to lack of lot information from the user facility.Because adequate inspection activities have been established and no other lot evidence is available, it was concluded that there is no evidence that nonconforming product exists in house or in field.Cook also reviewed product labeling.The current ifu for wireguide, tocwg_rev1, was reviewed and includes the following: precautions: manipulation of the wire guide requires appropriate imaging use caution not to force or over manipulate the wire guide when gaining access.When a wire guide through a metal cannula/needle, use caution as damage may to the 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 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.Based on the information provided, no return device, and the results of the investigation, cook has concluded a cause for the complaint cannot be established.It is not possible to rule out inadvertent user/procedural issues or concomitant device use.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.

• Brand Name: ROADRUNNER THE FIRM HYDROPHILIC WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 18270935
• MDR Text Key: 329776520
• Report Number: 1820334-2023-01637
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• PMA/PMN Number: K082536
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: RPC-035145
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TROCAR NEEDLE
• Patient Outcome(s): Required Intervention; Other
• Patient Sex: Male