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	07/03/2025
Type of Reportable Event	Malfunction
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.Since this half was no longer visible, and there was a risk of this structure entering the bloodstream if we continued inserting the catheter, it was necessary to exteriorize the catheter, remove half of the hemostatic valve, and reinsert the catheter.There were no immediate complications, such as bleeding or air embolism, and the fact that part of the catheter was already inside the sheath prevented blood from leaking." there was no patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (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.Since this half was no longer visible, and there was a risk of this structure entering the bloodstream if we continued inserting the catheter, it was necessary to exteriorize the catheter, remove half of the hemostatic valve, and reinsert the catheter.There were no immediate complications, such as bleeding or air embolism, and the fact that part of the catheter was already inside the sheath prevented blood from leaking." there was no patient harm or injury.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4) the customer returned one 16fr smartseal sheath for analysis.Signs of use were observed.Visual analysis revealed that the sheath was correctly torn along the extrusion perforation.The hemostasis valve was observed to be missing from one half of the split sheath hub.The dislodged half of the hemostasis valve was not returned.The other half of the split sheath was observed to be intact.Minor stretching of the sheath extrusion was noted at the proximal edge of the extrusion on both halves of the sheath.No other defects or anomalies were observed.A device history record review was performed, and one potential finding was identified.A scar has previously been initiated regarding sheath valve damage.Further investigation is required by the supplier to confirm if the failure mode of this complaint is the same as addressed in scar.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 from the sheath hub.No other defects were observed.Manufacturing was contacted as part of this investigation and it was determined that this damage is likely supplier related.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend for reports of this nature.

• 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: 22727174
• Report Number: 9680794-2025-00661
• Device Sequence Number: 8352731
• 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): 07/14/2025

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: 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: 07/14/2025
• Supplement Date Received by Manufacturer: 08/29/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/08/2025
• 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