MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARROW(R) VPS(R) ACCESS KIT; CATHETER, ULTRASOUND, INTRAVAS

Catalog Number	ASK-04001-DU13
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Picc nurse noticed wire was kinked on the end after removing it from the kit.A new kit was used to perform the procedure.No patient involvement with device reported.
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire assembly for analysis.No definite signs of use were observed.Visual analysis revealed that the guide wire contained one kink towards the distal tip.It was also noted that the guide wire was not entirely within the protective tubing when receiving the sample and the straightener tube was not returned.The kink measured 34mm from the distal tip.The overall length of the guide wire measured 60.4cm which is within the specification limits of 59.5cm - 60.5cm per the guide wire product drawing.The outer diameter of the guide wire measured 0.0175" which is within the specification limits of 0.0175" - 0.0180" per the guide wire product drawing.The guide wire was functionally tested per the guide wire instructions for use provided with this kit which instructs the user, "if using arrow raulerson syringe, advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was passed through a lab inventory arrow raulerson syringe (ars)/introducer needle subassembly.Little to no resistance was experienced.A manual tug test confirmed that the proximal weld was intact.Packaging was consulted and they confirmed that when assembled and packaged, the entire guide wire is placed within the protective tubing, so no part of the wire would be exposed to get damaged.Additionally, without the kit returned for analysis, it cannot be confirmed if damage to the kit during storage/shipping attributed to the observed kinking.Therefore, at this time, the cause of the kink cannot be determined.A device history record review was performed and no relevant findings were identified.The customer report of a kinked guide wire was confirmed through investigation of the returned sample.The guide wire contained one kink towards the distal end of the guide wire.Despite this, the guide wire passed all relevant dimensional and functional requirements, and a device history record review revealed no relevant findings.Based on the customer description, the sample received, and feedback from packaging, the potential root cause cannot be confirmed at this time.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
Picc nurse noticed wire was kinked on the end after removing it from the kit.A new kit was used to perform the procedure.No patient involvement with device reported.

• Brand Name: ARROW ARROW(R) VPS(R) ACCESS KIT
• Common Device Name: CATHETER, ULTRASOUND, INTRAVAS
• 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: 17825642
• Report Number: 9680794-2023-00710
• Device Sequence Number: 2302805
• Product Code: OBJ
• UDI-Device Identifier: 10801902201970
• UDI-Public: 10801902201970
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K103255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2024
• Device Catalogue Number: ASK-04001-DU13
• Device Lot Number: 33F23F0383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2023
• Supplement Date Received by Manufacturer: 10/18/2023
• Initial Report FDA Received Date: 09/27/2023
• Supplement Report FDA Received Date: 10/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2023
• 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
• Patient Sex: Unknown