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	03/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during the procedure, the physician found the catheter body was compressed." 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 procedure was completed after switching to another device.
Additional Manufacturer Narrative
(b)(4).The customer returned an opened psi kit for analysis including a sheath assembly.Visual analysis revealed a kink on the sheath body and protective guard.No signs of use in the form of biological material were observed.The kink in the sheath body was located 22 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 intact portion of the sheath body measured 4.64 mm which is within the specification limits of 4.59 mm - 4.71 mm per the sheath body extrusion product drawing.The master kit for this product was reviewed as a part of this investigation.The distal end of the guidewire advancer assembly is placed over the sheath body during packaging.The returned sheath and guidewire assembly were placed inside the tray according to the master kit.The location where the advancer is in contact with the sheath corresponds to the location of the kink.A device history record review was performed with no relevant findings.The customer report of a damaged sheath was confirmed by investigation of the returned sample.Visual analysis confirmed that the location of the kink corresponds to where the sheath is in contact with the guidewire advancer assembly in the packaging.Based on the damage observed on both the sheath and protective tubing, packaging design likely caused or contributed to this defect.A non-conformance was initiated to further investigate this issue.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: 25071475
• Report Number: 3006425876-2026-00472
• Device Sequence Number: 13445645
• 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