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

Model Number	IPN925076
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The arrow radial artery catheterization set (ref ra-04122) was being utilized to insert an arterial line in the patient.The catheter was stuck in the patient and part of arterial catheter broke off causing wire to bend.The provider had to make a superficial incision to get catheter and wire out.

• Brand Name: ARROW
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 24531858
• Report Number: 24531858
• Device Sequence Number: 21066276
• Product Code: DQX
• UDI-Device Identifier: 10801902210590
• UDI-Public: (01)10801902210590
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 01/08/2026
• Report Date (Section F): 01/08/2026

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: IPN925076
• Device Catalogue Number: RA-04122
• Device Lot Number: 14F24K0384
• 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: 03/06/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/06/2026
• 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: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 01/08/2026