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

Model Number	G04003
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a hair-like fiber was found to be in the sterile packaging of an amplatz extra-stiff support wire guide during an undisclosed procedure on an unknown patient.The discovery was made after the package was opened, but before the product made contact with the patient.An unspecified wire was used to complete the procedure successfully.The patient did not experience any adverse effects or require any additional procedures due to this occurrence.A photo provided by the customer to the manufacturer confirms the presence of a hair in the sealed packaging of the device.
Additional Manufacturer Narrative
E1 - title: lead technician.H3 - device evaluated by mfg?: the device will not be returned to the manufacturer.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.
Additional Manufacturer Narrative
Correction: d4, d9.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
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown, or unavailable.Investigation ¿ evaluation.It was reported that the customer found a hair-like fiber in the sterile packaging of an amplatz extra-stiff support wire guide when the device package was opened.The device was not used, and a non-specified wire guide was used to complete the procedure.No adverse effects were reported.Reviews of documentation including the complaint history, device history record (dhr), and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.Cook received one opened package with no device.A hair-like fiber was present in the package.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 revealed no recorded discrepancies relevant to the failure mode.A complaint history search identified no other events reported for the related failure mode.An expanded complaint history search was performed finding no complaints on the additional lots.The information provided upon review of the returned product indicates the product was manufactured out of specification.However, review of the dmr and dhr suggests that there are no additional nonconforming products in house or in the field.Cook did not review product labeling.This device is not packaged with an ifu.Based on the information provided, inspection of the returned device, and the results of the investigation, cook concludes this event to be due to manufacturing deficiencies.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 patient and/or event details has been received since the previous medwatch report was sent.

• 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: 22579442
• Report Number: 1820334-2025-00886
• Device Sequence Number: 7157640
• Product Code: DQX
• UDI-Device Identifier: 00827002040038
• UDI-Public: (01)00827002040038(17)300421(10)16566187
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/15/2025

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: G04003
• Device Catalogue Number: THSF-35-80-AES
• Device Lot Number: 16566187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Supplement Date Received by Manufacturer: 07/29/2025; 11/19/2025
• Initial Report FDA Received Date: 07/23/2025
• Supplement Report FDA Received Date: 08/01/2025; 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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