MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AM PICC 2L 5.5FRX55CM 130CM HYDR NIT SWG; INTRODUCER, CATHETER

Catalog Number	PR-45552-HPHNL
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "on (b)(6) 2026 at 14:45, dr.Began the picc line using ultrasound guidance to insert the introducer needle, 21 g x 7 cm.She did get blood return and then inserted the 0.018" guidewire.The guidewire was advanced but did not enter into the vessel.The needle was repositioned and she re-attempted advancing the guidewire.Guidewire did not advance, she pulled the guidewire out, and fluoroscopy showed the tip of the guidewire broke off and within the subcutaneous tissues of the right upper extremity." the piece of the guidewire remained inside the patient.There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "on (b)(6) 2026, at 1445, dr.Began the picc line using ultrasound guidance to insert the introducer needle, 21g x 7cm.She did get blood return and then inserted the 0.018" guidewire.The guidewire was advanced but did not enter into the vessel.The needle was repositioned and she re-attempted advancing the guidewire.Guidewire did not advance, she pulled the guidewire out, and fluoroscopy showed the tip of the guidewire broke off and within the subcutaneous tissues of the right upper extremity." the piece of the guidewire remained inside the patient.There was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one 45cm guide wire for analysis.Signs of use in the form of biological material were observed on the guide wire.Visual analysis confirmed that the guide wire was separated at the coiled section.Microscopic examination confirmed that the core and coil wires were broken.The core wire tip is tapered and discolored at the point of separation.The guide wire length from the proximal end to the point of separation on the core wire measured 40.2cm, which is not within the specification limits of 43.75cm-46.25cm per the guide wire product drawing.This is consistent with the customer report that a portion of the guide wire separated during use.The guide wire outer diameter measured 0.0175" , which is within the specification limits of 0.0160"-0.0185" per the guide wire product drawing.The guide wire was inserted through a lab inventory 21ga introducer needle.Resistance was encountered at the unraveled section.All functional sections passed with no issue.Performed per ifu statement, "raise thumb and pull arrow advancer approximately 4 - 8 cm away from introducer needle.Lower thumb onto arrow advancer and while maintaining a firm grip on guidewire, push assembly into needle to further advance guidewire.Continue until guidewire reaches desired depth".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire, peel-away sheath over tissue dilator, or tissue dilator as this can lead to venospasm, vessel perforation, bleeding, or component damage".The ifu also states, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested".The report of a separated guide wire was confirmed through examination of the returned sample.The guide wire core and coil wires were separated.The separated portion of the guide wire and the 21ga introducer needle were not returned.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 1 pound.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error likely contributed to this event; however, the probable cause of guide wire and needle resistance could not be determined based upon the information provided and without the needle being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW AM PICC 2L 5.5FRX55CM 130CM HYDR NIT SWG
• Common Device Name: INTRODUCER, CATHETER
• 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: 24638933
• Report Number: 9680794-2026-00199
• Device Sequence Number: 15913325
• Product Code: OFC
• UDI-Device Identifier: 10801902215793
• UDI-Public: (01)10801902215793(11)250805(17)261130(10)33F25D0022(21)
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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 Catalogue Number: PR-45552-HPHNL
• Device Lot Number: 33F25D0022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2025
• 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