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

Model Number	G07304
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/20/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Central line placement - upon removing guidewire resident realized guidewire was frayed indicating wire was not fully intact.Concern for possibility that frayed piece of the guidewire was inside patient.Retained foreign object identified on ct scan.

• Brand Name: COOK
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11472788
• Report Number: 11472788
• Device Sequence Number: 19784410
• Product Code: DQX
• UDI-Device Identifier: 00827002073043
• UDI-Public: (01)00827002073043(17)251103(10)13499625
• 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: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/22/2021
• Report Date (Section F): 02/22/2021

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: G07304
• Device Catalogue Number: STF-18-40-AUST
• Device Lot Number: 13499625
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Date Report Sent to FDA: 02/22/2021