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	Material Separation (1562); Unraveled Material (1664)
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 the spring wire guide (swg) was observed to be broken/damaged.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 for analysis.Signs of use were observed on the returned guidewire.Visual inspection identified unraveling of the guidewire towards the distal j-bend region, with separation observed near distal end.The separated section of the guidewire appeared unraveled and stretched.Microscopic examination of the separated guidewire section identified two areas of offset/misaligned spring coil near the distal end.The core wire was observed sticking out from the offset spring coil; however, the core wire appeared not kinked.The distal and proximal welds were present and appeared intact, full, and spherical.The spring coil and core wire remained attached at both the distal and proximal weld ends.The offset/misaligned spring coil locations on the separated guidewire were measured at 2 mm and 4 mm from the distal end.The separated core wire sections measured 599 mm and 2 mm, for a combined total core wire length of 601 mm.The total measured core wire length is within the specification limits of 600mm - 688mm per guidewire product drawing.This indicates that the core wire separation occurred directly adjacent to the distal weld.The returned guidewire outer diameter measured 0.797 mm, which is within the specification limits of 0.788mm - 0.826 mm per guidewire product drawing.The guidewire was functionally tested per the instructions for use provided with the kit which states: "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the returned guidewire was advanced through a lab inventory arrow raulerson syringe/18 ga introducer needle subassembly.The undamaged portion of the guidewire advanced through the arrow raulerson syringe without resistance.Resistance was encountered at the unraveled/separated portion of the guidewire when attempting to advance it through the introducer needle, and the guidewire could not be passed completely through the subassembly.Due to the severity of the guidewire separation and unraveling, the separated/unraveled portion could not be advanced through the arrow raulerson syringe/18 ga introducer needle subassembly.A manual tug test confirmed that both the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "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 ifu also states, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The reported guidewire separation was confirmed through examination of the returned sample.Visual inspection identified unraveling of the guidewire towards the distal j-bend region, with separation observed near distal end.The separated section of the guidewire appeared unraveled and stretched.Microscopic examination identified two areas of offset/misaligned spring coil near the distal end.The core wire was observed sticking out from the offset spring coil; however, the core wire appeared intact and not kinked.The distal and proximal welds were present and appeared intact, full, and spherical.The spring coil and core wire remained attached at both the distal and proximal weld ends.The guidewire met the applicable dimensional requirements during investigation testing.However, during functional testing, resistance was encountered at the unraveled/separated portion of the guidewire when attempting to advance it through the introducer needle, and the guidewire could not be passed completely through the subassembly.No manufacturing related defects or anomalies were identified in the returned guidewire during the investigation, and device history record review did not identify any manufacturing-related issues.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070 standard of 2.2 pounds force for this size wire.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 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: 25283192
• Report Number: 9680794-2026-00413
• Device Sequence Number: 21224530
• 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
• 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: 05/07/2026
• 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): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED.
• Patient Sex: Unknown