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	03/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).It was reported that the guidewire kinked during use.One guidewire assembly with an introducer needle was returned for evaluation.Visual inspection identified signs of use, including the presence of biological material within the straightener tube, needle hub, and on the guidewire.The guidewire was observed to be kinked proximal to the needle hub.The distal j-tip was slightly misshapen but remained intact.Microscopic examination confirmed the kink, and both distal and proximal welds were present and intact.Dimensional inspection confirmed that the overall length and outer diameter of the guidewire were within specification limits.The location of the kink was measured along the guidewire body.Functional testing was performed using the returned guidewire and introducer needle assembly.Resistance was encountered during advancement, which was attributed to the presence of the kink and biological material within the device.A device history record (dhr) review was conducted for relevant materials and batches.No manufacturing or quality-related issues were identified.A review of the applicable instructions for use (ifu) identified warnings against the application of excessive force, as this may result in component damage.The reported failure was confirmed based on the condition of the returned sample.Based on the available information, including the condition of the device and the reported use scenario, the most probable root cause is attributed to unintentional use error involving the application of undue force during use.No corrective or preventive actions were initiated, as the issue is not attributed to a manufacturing deficiency.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "the catheter cannot be properly connected/fitted.The set was replaced to resolve the issue.There was no reported patient harm or consequence.".

• 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: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24922436
• Report Number: 3006425876-2026-00411
• Device Sequence Number: 9153291
• Product Code: OFC
• UDI-Device Identifier: 10801902207095
• UDI-Public: (01)10801902207095(11)240305(17)280728(10)71F24B1526(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/25/2026

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: 71F24B1526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/05/2024
• 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
• Patient Sex: Unknown