MAUDE Adverse Event Report: COOK INC ROADRUNNER WIRE GUIDE; Endoscopic guidewire, gastroenterology-urology

Model Number N/A

Device Problems Difficult to Remove (1528); Unraveled Material (1664)

Patient Problem Insufficient Information (4580)

Event Date 07/15/2019

Event Type  malfunction  

Event Description

It was reported in a literature article that an 0.035 roadrunner pc hydrophilic wire guide would unravel and knot when being used in percutaneous nephrolithotomy (pcnl) procedures to delineate the pyelocalyceal system when ultrasound was unavailable in order to obtain renal access.The user would advance the wire guide through the ureteral catheter into the selected calyx.The user would then advance a large segment of the wire guide into the collecting system, allowing it to roll and provide delineation of the collecting system limits; the user could then visualize a more precise location to direct the puncture needle.A complication of this technique that was identified is the unraveling and subsequent knotting of the wire guide.The authors report at least one incident of the wire guide knotting which prevented wire guide removal.

Manufacturer Narrative

Common device name: product information (lot/rpn) is unavailable.Pma/510(k) number: product information (lot/rpn) is unknown.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

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

Manufacturer Narrative

Event description: it was reported in a literature article that an 0.035 roadrunner pc hydrophilic wire guide would unravel and knot when being used in percutaneous nephrolithotomy (pcnl) procedures to delineate the pyelocalyceal system when ultrasound was unavailable in order to obtain renal access.The user would advance the wire guide through the ureteral catheter into the selected calyx.The user would then advance a large segment of the wire guide into the collecting system, allowing it to roll and provide delineation of the collecting system limits; the user could then visualize a more precise location to direct the puncture needle.A complication of this technique that was identified is the unraveling and subsequent knotting of the wire guide.The authors report at least one incident of the wire guide knotting which prevented wire guide removal.Investigation evaluation: a document based investigation including review of the device master record and quality control procedures was conducted.The complaint is from literature and the complaint device was not return.Photos in the article (figure 5), show that the wire appears to be unraveled and in a knot.A review of relevant manufacturing and quality control documents was conducted.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.Roadrunner urology wire guides are not supplied with instructions for use.Cook could not complete a review of the device history record or search for other complaints from the product lot due to lack of lot information from the user facility.It was reported the wire guide was used to visualize the collecting system by advancing a large segment of the wire guide into the collecting system so that it rolls around itself and demarcates the limits of the collecting system.This is not consistent with the device¿s intended use.Cook has concluded the cause of the complaint is an unintended use error.Per the quality engineering risk assessment, no further action is required.The appropriate personnel have been notified, and we will continue to monitor 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.

• Brand Name: ROADRUNNER WIRE GUIDE
• Type of Device: 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: 16207335
• MDR Text Key: 309058486
• Report Number: 1820334-2023-00040
• Device Sequence Number: 1
• Product Code: OCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/27/2023
• 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