MAUDE Adverse Event Report: Arrow International LLC (subsidiary of Teleflex In ARROW; Wire, guide, catheter

Model Number	IPN925079
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Provider placed an arterial line at bedside.During the procedure, when retracting the wire, the wire stretched and stripped out of the catheter.X-ray ordered post-procedure.After obtaining x-ray part of the needle remained in the a-line catheter in the patient's arm.A-line discontinued at this time.Vascular consulted.The patient will have to go to surgery for retrieval.

• Brand Name: ARROW
• Common Device Name: Wire, guide, catheter
• Manufacturer (Section D): Arrow International LLC (subsidiary of Teleflex In; 3015 carrington mill blvd; morrisville NC 27560
• MDR Report Key: 50945230
• Report Number: 50945230
• Device Sequence Number: 21439872
• Product Code: DQX
• UDI-Device Identifier: 10801902210620
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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): 09/22/2026
• Report Date (Section F): 09/22/2026

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: IPN925079
• Device Catalogue Number: RA-04020
• Device Lot Number: 14F26E0231
• 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: 09/30/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/30/2026
• 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: Male
• Patient Weight: 183 LB
• Date Report Sent to FDA: 09/22/2026