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

Model Number	G00466
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Elderly female with history of hypertension, atrial fibrillation and recent shortness of breath.While preparing for a heart cath, the cook fixed core wire guide was bent upon taking it out of the package.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: 11411926
• Report Number: 11411926
• Device Sequence Number: 4711448
• Product Code: DQX
• UDI-Device Identifier: 00827002004665
• UDI-Public: (01)00827002004665(17)260122(10)13664642
• 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): 03/01/2021
• Report Date (Section F): 03/01/2021

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: G00466
• Device Catalogue Number: TSCF-25-145-3
• Device Lot Number: 13664642
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2021
• Patient Sequence Number: 1
• Patient Weight: 180
• Date Report Sent to FDA: 03/01/2021