MAUDE Adverse Event Report: Cook Inc SAFE-T-J FIXED CORE WIRE GUIDE; DQX Wire, Guide, Catheter

Model Number	G00527
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Codes	Pain (1994); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2026
Type of Reportable Event	Malfunction

• Brand Name: SAFE-T-J FIXED CORE WIRE GUIDE
• Common Device Name: DQX Wire, Guide, Catheter
• Manufacturer (Section D): Cook Inc; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; +1(812)339-2235
• MDR Report Key: 50101706
• Report Number: 1820334-2026-00783
• Device Sequence Number: 17469203
• Product Code: DQX
• UDI-Device Identifier: 00827002005273
• UDI-Public: (01)00827002005273(17)310313(10)17034441
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2026

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: G00527
• Device Catalogue Number: TSCF-35-80-15
• Device Lot Number: 17034441
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/17/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/27/2026
• Supplement Date Received by Manufacturer: 08/09/2026
• Initial Report FDA Received Date: 07/31/2026
• Supplement Report FDA Received Date: 08/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/13/2026
• 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: Female