MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTILUMEN/PSI SET; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	SI-11142
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during cvc insertion to the right subclavian vein, the md found the catheter body was compressed and the guidewire did not come out smoothly.When the physician pulled out the guidewire and catheter, the guidewire was twisted." it was later confirmed that all three devices were used on the same patient during the same procedure.The physician opened a 4th kit to complete the procedure.There were no reports of patient injury, harm, or adverse health consequences associated with the event.The patient's condition was reported as fine.No medical intervention was necessary, and the physician opened a 4th kit to complete the procedure.Please see the associated mdrs: ,3006425876-2026-00489, 3006425876-2026-00524 & 3006425876-2026-00488.
Additional Manufacturer Narrative
(b)(4) the customer returned one opened kit with guidewire assembly.Evidence of use was observed in the form of biological material.Microscopic examination of the guidewire confirmed the core wire was broken adjacent to the distal weld.The exposed distal core wire tip is tapered and discolored at the point of separation.Visual analysis of the dilator/sheath could not be performed as it was not returned.The kink in the guidewire was located 390mm from the distal tip.The overall length of the core wire measured 455 mm which is within the specification of 450-458 mm per guidewire product drawing.The outer diameter of the guidewire measured 0.850 mm which is within the specification of 0.838-0.877 mm per guidewire product drawing.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 this kit warns the user, "do not apply excessive force in placing or removing guidewire, dilator, or access device.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 customer report of a damaged guidewire was confirmed by visual inspection of the returned sample.The guidewire was unraveled from the distal tip.The dilator was not returned so dilator/guidewire resistance cannot be confirmed.No manufacturing defects were found during this investigation.Arrow guidewires 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 11070:2014 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.Based on these circumstances, without the dilator returned, the cause of the damage cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW MULTILUMEN/PSI SET
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: angela meister ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 25070919
• Report Number: 3006425876-2026-00473
• Device Sequence Number: 10407571
• Product Code: OFC
• UDI-Device Identifier: 10801902207095
• UDI-Public: (01)10801902207095(11)250428(17)290628(10)71F25D0925(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K002507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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: SI-11142
• Device Lot Number: 71F25D0925
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 05/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/28/2025
• 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
• Patient Sex: Unknown