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	Migration (4003)
Health Effect - Clinical Code	Pain (1994)
Date of Event	10/15/2025
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that "patient had chest pain during the insertion that went away.Patient visited ed on (b)(6) 2025, for chest pain that was more severe than they felt during the insertion.10/15/25 reported to greater baltimore medical center for chest pain, patient said it they were unable to lay down due to it being uncomfortable.Chest x-ray showed catheter appears short." additional information received from the customer reports "the team thinks that the catheter was placed on the shorter side and since it was inserted on the left, it may have migrated into the azygos creating the patient discomfort.The patient no longer needed the picc for therapy, so the team removed the picc and placed an arrow agba midline without any further issues." there was no patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "patient had chest pain during the insertion that went away.Patient visited ed on (b)(6) 2025 for chest pain that was more severe than they felt during the insertion.On (b)(6) 2025 reported to (b)(6) medical center for chest pain, patient said they were unable to lay down due to it's being uncomfortable.Chest x-ray showed catheter appears short." additional information received from the customer reports "the team thinks that the catheter was placed on the shorter side and since it was inserted on the left, it may have migrated into the azygos creating the patient discomfort.The patient no longer needed the picc for therapy, so the team removed the picc and placed an arrow agba midline without any further issues." there was no patient harm or injury.The patient's current condition is reported as "fine".

• 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: 23595996
• Report Number: 9680794-2025-00947
• Device Sequence Number: 10314588
• Product Code: LJS
• UDI-Device Identifier: 10801902208603
• UDI-Public: (01)10801902208603(11)250707(17)260831(10)33F25D0521(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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/31/2026
• Device Catalogue Number: DLX-45541-VPSB
• Device Lot Number: 33F25D0521
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 12/09/2025
• 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: 07/07/2025
• 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