MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CDC-42703-XPCN1A
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that in the emergency department (ed), the spring wire guide (swg) was observed to be broken/damaged but not separated.The timing and circumstances under which the swg damage occurred were not specified.Follow-up inquiries were made to obtain additional details regarding the device failure and patient outcome; however, no response or further information was received as of the date of the initial mdr submission.
Additional Manufacturer Narrative
(b)(4).The customer returned one guidewire.Signs of use in the form of biological material on the guidewire were observed.A minor bend in in the guidewire body was observed.The distal j-bend was slightly misshapen but intact.Both welds were present and were observed to be full and spherical.The overall length of the guidewire measured 603 mm which is within the specification of 600-608 mm per guidewire product drawing.The outer diameter of the guidewire measured 0.790 mm which is within the specification of 0.788-0.826 mm per guidewire product drawing.The guidewire was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guidewire was passed through the returned arrow raulerson syringe (ars) and introducer needle.The guidewire was able to pass with little to no 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 ifu provided with this kit warns the user , "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage." the report that the guidewire kinked during use was confirmed through examination of the returned sample and customer supplied photo.The guidewire had a minor bend in the body and the distal j-bend was slightly misshapen.The returned guidewire met all relevant dimensional and functional requirements, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guidewire 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.

• Brand Name: ARROW PI CVC KIT: 3-L 7 FR X 16 CM AGB
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: angela meister ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 25282879
• Report Number: 9680794-2026-00412
• Device Sequence Number: 10095053
• Product Code: LRS
• UDI-Device Identifier: 10801902162080
• UDI-Public: (01)10801902162080(11)260114(17)270731(10)33F25L0197(21)
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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
• Report Date (Section B): 04/29/2026

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 Catalogue Number: CDC-42703-XPCN1A
• Device Lot Number: 33F25L0197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2026
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/14/2026
• 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.
• Patient Sex: Unknown