MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CATH LAB SHEATH INTRO SET; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CP-07511
Medical Device Problem Codes	Component Incompatible (1108); Material Too Rigid or Stiff (1544); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).One unit of a cath lab sheath set, comprising a super arrow-flex sheath and dilator, was returned to teleflex for evaluation.Blood particulates were observed on the unit.During functional testing, the dilator was advanced through the lumen of the sheath, and minor resistance was noted at the distal section of the hub.The hub valve cap was then disassembled to expose the internal hemostasis body.Polymer delamination was observed, with the coil exposed.An irregular inner wall surface finish was also noted.Additionally, the dilator tip was observed to be damaged due to the interaction against the exposed coil.The dilator was advanced through the lumen of the sheath, and minor resistance was noted at the distal section of the hub.A device history record review was performed and no relevant findings were identified.Based on the returned product evaluation, the most likely root cause of the issue is manufacturing/process deficiency.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor for similar issues and trends.
Event or Problem Description
It was reported that during the procedure, the operating physician observed that the dilator could not be flushed and exhibited stiffness when advancing into the vessel.There were no reports of patient injury, harm, or adverse health consequences associated with this event.The patient's condition was reported as "fine." no additional medical intervention was required beyond removal of the affected device and replacement with another device to complete the procedure.Good faith efforts were made to obtain additional information regarding the reported device issue.A total of three attempts were made to contact the user facility; however, no response or additional information was received.

• Brand Name: ARROW CATH LAB SHEATH INTRO SET
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 25477367
• Report Number: 9680794-2026-00481
• Device Sequence Number: 9165050
• Product Code: LRS
• UDI-Device Identifier: 10801902210446
• UDI-Public: (01)10801902210446(11)240617(17)290531(10)14F24E0187(21)
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 06/08/2026

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: CP-07511
• Device Lot Number: 14F24E0187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 06/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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