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

Catalog Number	CS-15232-VFIE
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Foreign Body In Patient (2687)
Date of Event	11/17/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: early in the procedure when inserting the sheath the peel away portion broke apart and was lodged in the patient.This portion had to be removed before proceeding.Occurred during insertion in the int/ext jugula in the medical imaging department.The device was removed in it entirety and was replaced.The patient was reported as fine post the procedure.
Additional Manufacturer Narrative
Qn#(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
It was reported that: early in the procedure when inserting the sheath the peel away portion broke apart and was lodged in the patient.This portion had to be removed before proceeding.Occurred during insertion in the int/ext jugula in the medical imaging department.The device was removed in it entirety and was replaced.The patient was reported as fine post the procedure.
Additional Manufacturer Narrative
(b)(4).The customer returned, one safe d-pro sheath for evaluation.The dilator was not returned.Visual inspection of the sheath revealed, that the inner valve within one of the hub halves and the valve housing of the hub had broken and separated.The sheath appears to have torn down the score lines as intended.The sheath extrusion was still molded onto both tabs.Signs of use were observed, on the sheath.Microscopic examination confirmed, the damage.The length of the sheath body from the hub to the distal tip measured 130 mm or 5.118".Which is within, the specifications of 4.71"-5.31", per the sheath/dilator assembly product drawing.Functional testing could not be performed, due to the damage to the returned sheath.Manufacturing was contacted as a part of this complaint investigation.They stated, that a similar defect has been observed, before where the valve was damaged.They confirmed, that the damage is a supplier issue.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with this kit states: "do not use excessive force when introducing guidewire or tissue dilator, as this can lead to vessel perforation , bleeding or component damage.Precaution: dilators and catheters should be removed slowly from sheath.Rapid removal may damage valve resulting in blood flow through valve.Never advance or withdraw guidewire or sheath when resistance is met.Determine cause by fluoroscopy and take remedial action".The customer report of a sheath body damage was confirmed, by a complaint investigation of the returned sample.The inner valve within one of the hub halves and the valve housing of that hub half had broken and separated.Based on the sample returned and the fact that the sheath is a purchased component and comments from manufacturing.The observed, defect is a supplier issue.A non-conformance was initiated to further investigate this issue.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported, that early in the procedure.When inserting the sheath, the peel away portion broke apart and was lodged in the patient.This portion had to be removed before proceeding.Occurred, during insertion in the int/ext jugula in the medical imaging department.The device was removed in it entirety and was replaced.The patient was reported, as fine post the procedure.

• 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: 18347059
• Report Number: 9680794-2023-01007
• Device Sequence Number: 20386430
• Product Code: MSD
• UDI-Device Identifier: 10801902112801
• UDI-Public: 10801902112801
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/20/2023

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 Expiration Date: 04/30/2026
• Device Catalogue Number: CS-15232-VFIE
• Device Lot Number: 33F23D0855
• 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: 11/20/2023
• Supplement Date Received by Manufacturer: 01/04/2024; 05/02/2024
• Initial Report FDA Received Date: 12/18/2023
• Supplement Report FDA Received Date: 01/08/2024; 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2023
• 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; NOT REPORTED
• Patient Sex: Unknown