MAUDE Adverse Event Report: TELEFLEX INCORPORATED ARROW; WIRE, GUIDE, CATHETER

Model Number	IPN922856
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/27/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
During removal of an arterial line, the catheter remained in the patient requiring surgical intervention for removal.

• Brand Name: ARROW
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 20189072
• Report Number: 20189072
• Device Sequence Number: 15204384
• Product Code: DQX
• UDI-Device Identifier: 10801902203004
• UDI-Public: (01)10801902203004
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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): 04/16/2024
• Report Date (Section F): 04/16/2024

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: IPN922856
• Device Catalogue Number: FA-04018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/11/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/11/2024
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 17 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Date Report Sent to FDA: 04/16/2024