MAUDE Adverse Event Report: COOK INCORPORATED COOK; WIRE, GUIDE, CATHETER

Model Number	G00471
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/10/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly male with coronary artery disease.When the fixed core wire guide was taken out of the package, the tip of the wire was straight.It was not able to regain the "j" shape.This device was not used on the patient.

• Brand Name: COOK
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11494348
• Report Number: 11494348
• Device Sequence Number: 3945451
• Product Code: DQX
• UDI-Device Identifier: 00827002004719
• UDI-Public: (01)00827002004719(17)260125(10)13652912
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 03/12/2021
• Report Date (Section F): 03/12/2021

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: G00471
• Device Catalogue Number: TSCF-25-260-3
• Device Lot Number: 13652912
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/16/2021
• Patient Sequence Number: 1
• Patient Weight: 77
• Date Report Sent to FDA: 03/12/2021