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	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "in order to insert catheter, skin incision was made.Everything was going well until smartsealhemostatis dialysis sheath was introduced.Sheath was damaged.Wing of sheath tore off.Procedure was completed because tool was taken to hold sheath without wing.And sheath tore off in vessel.After completed procedure, catheter was patent, functional.X-ray of catheter tip was checked.Correctly positioned." the sheath was completely removed.There was no delay to therapy.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer submitted four photos for analysis.The photos show a 16fr smartseal sheath and lidstock.Visual analysis of the photos revealed that the sheath did not tear correctly.The two halves of the sheath extrusion appeared wavy and non-uniform along one side, indicating stretching.Additionally, one of the sheath hub tabs was separated from the sheath extrusion.Therefore, the customer report is confirmed.The customer also returned one 16fr smartseal sheath and lidstock for analysis.Signs of use were observed.Visual analysis of the returned sheath confirmed the deformation and stretching of the sheath extrusion as observed in the customer supplied photos.One of the sheath hub tabs was observed to be separated from the sheath extrusion.This damage is consistent with incorrect tearing of the sheath.Additionally, the distal portion of the hemostasis valve was not fully split apart.Manufacturing was contacted as part of this complaint investigation.It was confirmed that the observed incorrect tearing of the sheath is a supplier defect.A device history record review was performed and no relevant findings were identified.The instructions for use (ifu) provided with this kit instructs the user, "sharply snap the tabs of valve housing in a plane perpendicular to the long axis of sheath to split valve and split sheath apart while withdrawing from vessel." the report of a sheath tearing incorrectly was confirmed by investigation of the returned sample.Visual analysis revealed that the sheath did not tear correctly.The sheath extrusion along the score line appeared wavy and non-uniform, indicating stretching.Manufacturing was contacted as part of this complaint investigation, and it was confirmed that this is a supplier defect.A non-conformance has been initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "in order to insert catheter, skin incision was made.Everything was going well until smartsealhemostatis dialysis sheath was introduced.Sheath was damaged.Wing of sheath tore off.Procedure was completed because tool was taken to hold sheath without wing.And sheath tore off in vessel.After completed procedure, catheter was patent, functional.X-ray of catheter tip was checked.Correctly positioned." the sheath was completely removed.There was no delay to therapy.No medical intervention required.The patient's current condition is reported as "fine".

• 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: 21846775
• Report Number: 9680794-2025-00300
• Device Sequence Number: 8607518
• Product Code: MSD
• UDI-Device Identifier: 10801902112801
• UDI-Public: (01)10801902112801(11)240905(17)270831(10)33F24G0169(21)
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2025

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: 33F24G0169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/26/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 05/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2024
• 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.; NOT REPORTED.
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 109 KG