MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM; CATHETER, HEMODIALYSIS, IMPLA

Model Number	IPN920489
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "one half of the introducer sheath's hemostatic valve became completely detached when the catheter was inserted, having been pushed by the catheter tip.Since this half was no longer visible, and there was a risk of this structure entering circulation if we continued introducing the catheter, it was necessary to remove the sheath and introduce a new introducer sheath.Without immediate complications, particularly hemorrhagic complications, the fact that part of the catheter was already inside the sheath did not allow blood to leak out." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).One 16 fr safe sheath d-pro was returned for investigation.Signs of use were observed in the form of blood particulates on the device and in the lumen.Visual inspection confirmed that half of the valve was detached and is missing from the returned unit.Upon analysis, it was noted that the valve was torn unevenly.The peel away tabs were intact and no other defects were observed on the sheath valve nor body.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding , or component damage." the report of a damaged safe sheath d-pro valve was confirmed through examination of the returned sample.Visual analysis revealed that half of the sheath valve had completely detached from the device.It appeared that the valve did not separate evenly.No additional visual defects were observed on the sheath valve or tab.The manufacturing facility was contacted as part of this investigation.The site stated that similar defects have been observed where the valve was damaged in this manner.The root cause is supplier related as the device is a purchased component.Therefore, the damage identified has been determined to be a supplier related issue.A non-conformance was 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 "one half of the introducer sheath's hemostatic valve became completely detached when the catheter was inserted, having been pushed by the catheter tip.Since this half was no longer visible, and there was a risk of this structure entering circulation if we continued introducing the catheter, it was necessary to remove the sheath and introduce a new introducer sheath.Without immediate complications, particularly hemorrhagic complications, the fact that part of the catheter was already inside the sheath did not allow blood to leak out." there was no medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 19 CM
• 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: 21976569
• Report Number: 9680794-2025-00386
• Device Sequence Number: 9253139
• Product Code: MSD
• UDI-Device Identifier: 00801902096333
• UDI-Public: (01)00801902096333(11)240808(17)270731(10)33F24H0038(21)
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/16/2025

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: IPN920489
• Device Catalogue Number: CS-15242-VSP
• Device Lot Number: 33F24H0038
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2024
• 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 Sex: Unknown