MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-L 15 FR X 55 CM RETR; CATHETER, HEMODIALYSIS, IMPLA

Catalog Number	CS-15552-VFE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "doctor called to say there was an issue with the product.I have collected the sample and notice the dilator tip is fractured.Dr could not speak to me regarding how the dilator tip broke." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn#(b)(4).The customer provided one image showing a safe sheath dilator.Signs of use were visible.Visual analysis revealed that the dilator tip was separated adjacent to the distal opening.The extrusion at the distal opening also appeared defective.The customer also returned one safe sheath/dilator assembly for analysis.Signs of use in the form of biological material were observed.Visual analysis revealed that the dilator tip was partially separated adjacent to the distal opening.Microscopic examination confirmed the partial separation and revealed that a section of the tip (at the distal opening) was fully separated.This separated piece was not returned.No other defects or anomalies were observed.The dilator outer diameter measured 0.2095", which is within the specification limits of 0.2090"-0.2120" per the safe sheath d-pro product drawing.The inner diameter at the distal tip measured 0.038", which is within the specification limits of 0.038"-0.039" per the safe sheath d-pro product drawing.A lab inventory guide wire was inserted through the distal tip.Despite the damage to the distal opening and the partial separation adjacent to the tip, the guide wire was able to pass completely through the extrusion.No abnormal resistance or blockages were observed.Performed per ifu statement, "thread dilator/sheath assembly over guidewire".A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs 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 separated dilator was confirmed through complaint investigation of the returned sample.Visual analysis revealed two points of separation towards the distal end.Based on the customer report, the sample received, and the comments from manufacturing, the root cause for this complaint is supplier related.A non-conformance was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "doctor called to say there was an issue with the product.I have collected the sample and notice the dilator tip is fractured.Dr could not speak to me regarding how the dilator tip broke." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW HEMODIALYSIS SET: 2-L 15 FR X 55 CM RETR
• 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: 20951515
• Report Number: 9680794-2024-01243
• Device Sequence Number: 18191585
• Product Code: MSD
• UDI-Device Identifier: 10801902112726
• UDI-Public: (01)10801902112726(11)230905(17)260831(10)33F23G0551(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K141051
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2024

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 Expiration Date: 08/31/2026
• Device Catalogue Number: CS-15552-VFE
• Device Lot Number: 33F23G0551
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/21/2024
• Supplement Date Received by Manufacturer: 01/07/2025
• Initial Report FDA Received Date: 12/17/2024
• Supplement Report FDA Received Date: 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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
• Patient Sex: Unknown