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

Catalog Number	CS-15242-VSP
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "one half of the introducer sheath's hemostatic valve completely detached during catheter insertion, having been pushed into the sheath between the two branches." it was necessary to exteriorize the catheter, remove half of the hemostatic valve, and reinsert the catheter." the user changed to a new sheath.There was no patient harm or injury.The patient's current condition is reported as "unknown".
Additional Manufacturer Narrative
(b)(4).The customer returned one 16fr smartseal sheath and lidstock from a hemodialysis kit for analysis.Signs of use were observed.Visual analysis revealed that one half of the hemostasis valve was dislodged and partially rotated within the hub of the sheath.No other defects or anomalies were observed.A device history record review was performed, and one relevant finding was identified.A non-conformance was initiated regarding "smartseal sheath valve damaged" for material cs-15242-vsp, lot 33f24m0039.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 customer report of a damaged hemostasis valve was able to be confirmed through investigation of the returned sample.Visual analysis revealed that one half of the hemostasis valve had become dislodged within the sheath hub.No other defects were observed.Manufacturing was contacted and it was determined that this damage is likely supplier related.A non-conformance was opened to address this issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "one half of the introducer sheath's hemostatic valve completely detached during catheter insertion, having been pushed into the sheath between the two branches." it was necessary to exteriorize the catheter, remove half of the hemostatic valve, and reinsert the catheter." the user changed to a new sheath.There was no patient harm or injury.The patient's current condition is reported as "unknown".

• 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: 23166473
• Report Number: 9680794-2025-00800
• Device Sequence Number: 8882051
• Product Code: MSD
• UDI-Device Identifier: 00801902096333
• UDI-Public: (01)00801902096333(11)241220(17)271130(10)33F24M0039(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: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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
• Device Catalogue Number: CS-15242-VSP
• Device Lot Number: 33F24M0039
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2024
• 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