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

Catalog Number	CS-15282-VSP
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "the valve in the sheath came loose and tilted, preventing insertion of the dialysis catheter.As a result, a new set had to be used".The condition of the patient is reported to be 'fine'.
Event or Problem Description
It was reported that "the valve in the sheath came loose and tilted, preventing insertion of the dialysis catheter.As a result, a new set had to be used".The condition of the patient is reported to be 'fine'.
Additional Manufacturer Narrative
(b)(4).The customer returned one, safe d-pro peel-away sheath for analysis.Signs of use were observed in the form of biological material on the device.Visual analysis revealed the sheath valve had separated within the sheath valve body and was rotated within the device.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 there was one potential finding.A non-conformance was initiated for lots 33p24a0316, 33p24a0312, 33p24a0313 regarding smartseal sheath valve damaged.Review of the non-conformance confirmed that the failure mode of this complaint is the same as the non-conformance 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 smart seal sheath valve was confirmed through examination of the returned sample.Visual analysis revealed that the sheath valve had completely separated from the hub and was loose from the device.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 a similar defect has 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.

• Brand Name: ARROW HEMODIALYSIS KIT: 2-L 15 FR X 23 CM
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21111844
• Report Number: 9680794-2025-00035
• Device Sequence Number: 8719461
• Product Code: MSD
• UDI-Device Identifier: 00801902096388
• UDI-Public: (01)00801902096388(11)240301(17)270228(10)33F24B0010(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K111117
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2024

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 Catalogue Number: CS-15282-VSP
• Device Lot Number: 33F24B0010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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: 75 YR
• Patient Sex: Unknown