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

Catalog Number	SI-11142
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) the customer returned one guidewire assembly and dilator advanced within a sheath for analysis.Evidence of use was observed in the form of biological material.Visual analysis of the returned catheter showed a kink in the catheter body.Microscopic examination confirmed the damage.The kink in the sheath body was located 29 mm from the juncture hub.The overall length of the sheath body measured 99 mm which is within the specification limits of 98 mm - 102 mm per sheath assembly product drawing.The outer diameter of the sheath body measured 4.59 mm which is within the specification limits of 4.59 mm - 4.71 mm per the sheath body extrusion product drawing.Functional inspection of the guidewire was performed per the instructions for use (ifu) provided with the kit which states, "thread tapered tip of dilator/access device assembly over guidewire.Sufficient guidewire length must remain exposed at hub end of device to maintain a firm grip on guidewire.Grasping near skin, advance assembly with slight twisting motion to a depth sufficient to enter vessel.Dilator may be partially withdrawn to facilitate advancement of access device through tortuous vessel." the returned dilator was threaded through the catheter and the returned guidewire was advanced through the dilator and was able to advance with minimal resistance.A device history record review was performed and no relevant findings were identified.The 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 kinked catheter was confirmed by visual inspection of the customer returned sample.The damage aligns with previously observed damage due to packaging; however, as the protective sheath was not returned, and the customer could not confirm if the damage was observed before or after use.It therefore cannot be determined when the damage occurred.Based on these circumstances, the root cause of this event cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.
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: 3006425876-2026-00473, 3006425876-2026-00489, & 3006425876-2026-00488.

• 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: 25071333
• Report Number: 3006425876-2026-00524
• Device Sequence Number: 21517246
• 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): 04/16/2026

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: 04/16/2026
• 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