MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 1-LUMEN 5 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	AK-04301-J
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the user found the swg was kinked when inserting it during the procedure.Therefore, a new kit was used to complete the procedure.No injury to the patient occurred.The similar issue has occurred about 3 times in total since last year." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associate mdr numbers include: 3006425876-2026-00145 and 3006425876-2026-00146.
Additional Manufacturer Narrative
(b)(4).The customer returned one guidewire for analysis.Sign of use was observed on the guidewire.One kink was identified on the guidewire body.The distal j-bend was misshapen.Microscopic examination confirmed that both welds were present and appeared full and spherical.One kink on the guidewire was located at 205mm from the proximal end.The overall length of the guide wire measured 601mm, which is within the specification limits of 596mm-604mm per guide wire product drawing.The outer diameter of the guide wire measured 0.794mm, which is within the specification limits of 0.788mm-0.826mm per guide wire product drawing.The guidewire was functionally tested in accordance with the product instructions for use (ifu).The ifu provided with this kit instructs the user to "advance the guidewire into the arrow raulerson syringe approximately 10 cm until it passes through the syringe valves or into the introducer needle." functional testing was performed by advancing the guidewire through a laboratory inventory arrow raulerson syringe (ars) and a laboratory inventory 18-gauge introducer needle.Minimal resistance was observed at the kinked locations.The undamaged portions of the guidewire advanced through the ars and introducer needle without resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution , "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 that the guidewire was observed kinked during use was confirmed through investigation of the returned sample.Visual examination identified one kink on the guidewire body.The distal j-bend was misshapen.Signs of use were observed on the returned guidewire.The returned guide wire met all relevant dimensional/functional requirements, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the user found the swg was kinked when inserting it during the procedure.Therefore, a new kit was used to complete the procedure.No injury to the patient occurred.The similar issue has occurred about 3 times in total since last year." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associate mdr numbers include: 3006425876-2026-00145, 3006425876-2026-00146, and 3006425876-2026-00147.

• Brand Name: ARROW CVC KIT: 1-LUMEN 5 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24303257
• Report Number: 3006425876-2026-00147
• Device Sequence Number: 5239837
• Product Code: DQY
• UDI-Device Identifier: 30801902169076
• UDI-Public: (01)30801902169076(11)240611(17)270531(10)71F24E0973(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K862056
• 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): 01/15/2026

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
• Device Catalogue Number: AK-04301-J
• Device Lot Number: 71F24E0973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2024
• 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