MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AGBA PICC G4 STYLET: 1L 4.5FR X 55CM BP; CATHETER INTRAVASCULAR THERAPE

Catalog Number	DLX-45541-VPSB
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Pain (1994)
Date of Event	07/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "patient had racing heart during insertion." additional information received states "when patient visited the ed for chest pains, the initial x ray shows the catheter tip deep into the right atrium.The vascular access team pulled the catheter back 3cm.The patient still complained of chest pain; therefore, the team pulled back an additional 1cm for a total for 4cm retracted.Final x ray shows proper placement at 12cm external (line trimmed to 50cm.Vitals were normal when patient visited the ed.No further issues." the patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "patient had racing heart during insertion." additional information received states "when patient visited the ed for chest pains, the initial x ray shows the catheter tip deep into the right atrium.The vascular access team pulled the catheter back 3cm.The patient still complained of chest pain; therefore, the team pulled back an additional 1cm for a total for 4cm retracted.Final x ray shows proper placement at 12cm external (line trimmed to 50cm.Vitals were normal when patient visited the ed.No further issues." the patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AGBA PICC G4 STYLET: 1L 4.5FR X 55CM BP
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23595547
• Report Number: 9680794-2025-00979
• Device Sequence Number: 21166307
• Product Code: LJS
• UDI-Device Identifier: 10801902208603
• UDI-Public: (01)10801902208603(11)250506(17)260820(10)33F25D0064(21)
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K122545
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2025

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 Expiration Date: 08/20/2026
• Device Catalogue Number: DLX-45541-VPSB
• Device Lot Number: 33F25D0064
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 11/19/2025
• Supplement Report FDA Received Date: 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown