MAUDE Adverse Event Report: COOK INCORPORATED COOK AUSTRALIAN MANDRIL WIRE GUIDE STAINLESS STEEL; WIRE, GUIDE, CATHETER

Model Number	G07304
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Attending was placing a cvl in a patient who was requiring vasopressors.18g wire uncoiled inside of the patient.The attending was able to remove the guidewire without harm to the patient.Multiple wires were used and the line was unsuccessful.

• Brand Name: COOK AUSTRALIAN MANDRIL WIRE GUIDE STAINLESS STEEL
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 13450825
• Report Number: 13450825
• Device Sequence Number: 5047350
• Product Code: DQX
• UDI-Device Identifier: 00827002073043
• UDI-Public: (01)00827002073043(17)260511
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 01/25/2022
• Report Date (Section F): 01/25/2022

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: G07304
• Device Catalogue Number: STF-18-40-AUST
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 02/04/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/25/2022