MAUDE Adverse Event Report: COOK INC AMPLATZ EXTRA STIFF SUPPORT WIRE GUIDE; DQX, WIRE, GUIDE, CATHETER

Model Number	G04237
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1- phone number: (b)(6).E1- postal code: (b)(6).H3- device evaluation anticipated but not yet begun.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.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.
Event or Problem Description
It was reported that a hair-like substance was found inside the packaging of an amplatz extra stiff support wire guide.Upon opening the package, a nurse noticed the foreign matter prior to a biliary drainage procedure, during which a drainage tube was to be inserted percutaneously into the right bile duct branch.The procedure was completed using a new same-like device.It was confirmed that no damage to the package was noticed, and the device was stored vertically.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Investigation ¿ evaluation it was reported that a hair-like substance was found inside the packaging of an amplatz extra stiff support wire guide.Upon opening the package, a nurse noticed the foreign matter prior to a biliary drainage procedure, during which a drainage tube was to be inserted percutaneously into the right bile duct branch.The procedure was completed using a new same-like device.It was confirmed that no damage to the package was noticed, and the device was stored vertically.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of documentation including the complaint history, device history record (dhr), instructions for use (ifu), and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.One prior to use device was returned for investigation.A hair-like fiber was found in the cook end seal.Additionally, 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.There are no other complaints on this lot at the time of this investigation.The information provided upon review of the returned device indicates the device was manufactured out of specification.However, review of the dmr and dhr suggests that there are no additional nonconforming devices in house or in the field.Cook did not review product labeling.This lot is not supplied with an instructions for use (ifu) pamphlet.Based on the information provided, inspection of the returned device, and the results of the investigation, cook concludes this event to be due to a manufacturing deficiency.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: AMPLATZ EXTRA STIFF SUPPORT 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: 21963657
• Report Number: 1820334-2025-00478
• Device Sequence Number: 15272094
• Product Code: DQX
• UDI-Device Identifier: 00827002042377
• UDI-Public: (01)00827002042377(17)291230(10)16400197
• Combination Product (Y/N): N
• PMA/510(K) Number: K171764
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: G04237
• Device Catalogue Number: THSCF-35-80-3-AES
• Device Lot Number: 16400197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 10/21/2025
• Initial Report FDA Received Date: 05/05/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2024
• 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