MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM ANTE; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN920476
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that during the insertion of a chronic hemodialysis catheter (chdc), when attempting to insert the peel-away sheath and dilator into the vessel, the sheath prematurely split longitudinally.Additional information received from the user facility indicated that prior to dilation, an approximately 1 cm skin incision was made over the spring wire guide (swg), and blunt dissection was performed using clamps to facilitate tunneling of the chdc.The dilators and peel-away sheath were advanced in the usual manner using a gentle twisting motion.However, in this case, the peel-away sheath split immediately upon attempted insertion, preventing advancement or initiation of the twisting motion.The affected device was removed, and the procedure was successfully completed using a replacement device.The event resulted in an approximate 10-15 minute delay in the procedure.There were no reports of patient injury, harm, or adverse health consequences associated with this event other than the procedural delay.No additional medical intervention was required beyond that described.

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 23 CM ANTE
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 25491517
• Report Number: 9680794-2026-00447
• Device Sequence Number: 18624272
• Product Code: PPO
• UDI-Device Identifier: 10801902154184
• UDI-Public: (01)10801902154184(11)250929(17)280517(10)33F25H0293(21)
• Combination Product (Y/N): N
• Initial Reporter Country: EN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2026

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 Model Number: IPN920476
• Device Catalogue Number: CS-15232-VFIE
• Device Lot Number: 33F25H0293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/29/2025
• 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