MAUDE Adverse Event Report: COOK INC COPE MANDRIL WIRE GUIDE; DQX, WIRE, GUIDE, CATHETER

Model Number	G05183
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cope mandril wire guide unraveled during a percutaneous transhepatic cholangiography procedure in an unknown patient.It was initially reported that the wire guide was "faulty".Additional information provided (b)(6)2025 clarified that, upon removal of the access wire from the insertion needle, the wire was found to be unraveled.To successfully gain access, four additional wires were used.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.The three other unraveled wires are referenced in reports with patient identifiers: (b)(6).
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.E1 - phone number: (b)(6).H3: device evaluation anticipated but not yet begun, awaiting device return.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 or that a death or serious injury occurred; nor is it admission that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
Additional Manufacturer Narrative
Investigation ¿ evaluation.H3 - device evaluated by mfg? only an opened package was received without the device.It was reported that a cope mandril wire guide unraveled during a percutaneous transhepatic cholangiography procedure in an unknown patient.Upon removal of the access wire from the insertion needle, the wire was found to be unraveled.To successfully gain access, four additional wires were used.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.No portion of the device remained within the patient.The three other unraveled wires are referenced in reports with patient identifiers: (b)(6).Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), drawings, specifications, and quality control procedures of the device were conducted during the investigation.One opened package with no product was received.Due to no device return, cook was not able to perform a device failure analysis.However, a document-based investigation evaluation was performed.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 dhr for the reported complaint device lot did not reveal any relevant nonconformances.It should be noted that there are no other complaints on this lot at the time of this investigation.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in the field.Cook also reviewed product labeling.The wire guide holder is supplied with an l_scor label attached indicating not to withdraw or manipulate the wire guide through a needle.The ifu [ t_mwg_rev0] packaged with the device contains the following in relation to the reported failure mode: warnings: "this product is a delicate instrument.Avoid forceful angulation.Avoid manipulating or withdrawing the wire guide back through a metal needle or cannula.A sharp edge may scrape or shear material from the wire guide." precautions: "when you use the wire guide with another device, consider the end hole size and the length of the device in order to ensure a proper fit between the wire guide and the device." instructions for use: "3.If needed, insert a wire guide insertion tool (provided) through the valve assembly or hub of the guiding sheath or other interventional device.Insert the tip of the wire guide through the insertion tool and advance the wire guide to the desired location.4.Attach a torque device to the wire guide (if provided).5.Standard wire guide techniques may now be employed." how supplied: "upon removal from package, inspect the product to ensure no damage has occurred." based on the information provided, no product returned, and the results of the investigation, cook determined this event to be due to a failure to follow instructions.It was reported that the customer was removing the device back through the access needle.The device is supplied with a label and ifu indicating not to withdraw or manipulate the device through a needle.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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: COPE MANDRIL WIRE GUIDE
• Common Device Name: DQX, WIRE, GUIDE, CATHETER
• 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: 23041739
• Report Number: 1820334-2025-01137
• Device Sequence Number: 21304563
• Product Code: DQX
• UDI-Device Identifier: 00827002051836
• UDI-Public: (01)00827002051836(17)291106(10)16329183
• Combination Product (Y/N): N
• PMA/510(K) Number: K171997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G05183
• Device Catalogue Number: PMG-18SP-60-COPE
• Device Lot Number: 16329183
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2025
• Supplement Date Received by Manufacturer: 12/08/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 12/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/06/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown