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 Codes	Mechanical Problem (1384); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "on (b)(6) 2024 an attempt was made to place a catheter, but the sheath tore during insertion.Reason broken: sheath for puncturing: the distal end (the valve) has a defect in the wing and is open but does not close back as it should".The device was removed and replaced.The patient's current condition is reported as "fine".
Event or Problem Description
It was reported that "on (b)(6) 2024 an attempt was made to place a catheter, but the sheath tore during insertion.Reason broken: sheath for puncturing: the distal end (the valve) has a defect in the wing and is open but does not close back as it should".The device was removed and replaced.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one, safe d-pro peel-away sheath and the product lidstock for analysis.The dilator component was not within the sheath and was not returned.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 loose within the device.The peel-away tabs were intact, and no defects were observed on the sheath valve nor body.The manufacturing facility was previously contacted regarding complaints of this nature.The site stated that a similar defect has been observed where the valve was damaged in this manner.The damage identified has been determined to be a supplier related issue.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 smart seal sheath valve was confirmed through examination of the returned sample.Visual analysis revealed that one half of the sheath valve had separated from the hub and was loose from the device.Further microscopic examination revealed visual evidence of adhesive on the internal sheath tab where the valve became separated.No visual evidence of adhesive was identified on the back of the separated sheath valve half.No additional visual defects were observed on the sheath valve or tab.The manufacturing facility was previously contacted regarding complaints of this nature.The site stated that a similar defect has been observed where the valve was damaged in this manner.The root cause is supplier related since 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 (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: 20696372
• Report Number: 9680794-2024-01107
• Device Sequence Number: 6583681
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2024

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: 11/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 11/27/2024
• 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: 71 YR
• Patient Sex: Unknown