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

Model Number	G03562
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 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
As reported, upon opening the undamaged device package, prior to use for an unspecified procedure involving placement of a stent, the tip of an amplatz extra-stiff support wire guide was found to be damaged.The device did not make patient contact, and another wire was used to complete the procedure.A photo provided by the customer shows the mandril protruding from the wire.The patient did not require any additional procedures or experience any adverse effects due to this event.
Additional Manufacturer Narrative
Correction: d4 primary udi.Summary of event: as reported, upon opening the undamaged device package, prior to use for an unspecified procedure involving placement of a stent, the tip of an amplatz extra-stiff support wire guide was found to be damaged.The device did not make patient contact, and another wire was used to complete the procedure.A photo provided by the customer shows the mandril protruding from the wire.The patient did not require any additional procedures or experience any adverse effects due to this event.Investigation evaluation: reviews of the complaint history, device history record (dhr), manufacturing instructions, and quality control procedures were conducted during the investigation.A visual inspection of the complaint device was also conducted.The complaint device was returned to cook for investigation.The mandril was protruding at approximately 4cm from distal end of the device.A document-based investigation evaluation was performed.A review of the device history record and complaint history found no discrepancies or additional relevant complaints on the lot.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The information provided upon review of the returned device, complaint file, dmr, and dhr suggests that there is evidence that the device was manufactured to specification.Based on the information provided and the results of the investigation, cook has concluded the cause of this event is due to the shipping/handling of the device.There are no manufacturing or design deficiencies that can be confirmed at this time.The risk analysis for this failure mode was reviewed, and no additional escalation was required.The appropriate personnel have been notified, and cook will continue to monitor for similar events.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: 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: 23051634
• Report Number: 1820334-2025-01143
• Device Sequence Number: 9824505
• Product Code: DQX
• UDI-Device Identifier: 00827002035621
• UDI-Public: (01)00827002035621(17)300625(10)16659444
• 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): 02/05/2026

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: G03562
• Device Catalogue Number: THSF-35-260-AES
• Device Lot Number: 16659444
• 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: 09/04/2025
• Supplement Date Received by Manufacturer: 01/19/2026
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 02/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2025
• 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