MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC SPRING WIRE GUIDE COMPONENT; CATHETER HEMODIALYSIS IMPLANTE

Catalog Number	AW-04435
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported that while advancing the swg into the vessel, the swg kinked.As a result, a new kit was used.No patient harm or injury.The patient status is reported as "fine".
Event or Problem Description
It was reported that while advancing the swg into the vessel, the swg kinked.As a result, a new kit was used.No patient harm or injury.The patient status is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The customer returned one swg in its advancer for analysis.The needle was not returned , and an introducer needle is not a component within the reported finished good.No signs-of-use were observed on the sample.Visual analysis revealed that there were two kinks towards the distal end of the guide wire.The distal j-bend was intact.Microscopic examination revealed that both welds were full and intact.Visual analysis could not be performed on the needle as it was not returned, and it is not a component in the kit.The kinks on the guide wire measured 374mm and 392mm from the proximal tip.The overall length of the guide wire measured 356mm which is not within the specification of 596-604 mm per guide wire product drawing.This suggests that the customer returned the incorrect guide wire (45cm instead of a 60cm) or reported the incorrect finished good.Dimensional analysis could not be performed on the needle as it was not returned, and an introducer needle is not part of the reported finished good.The guide wire was functionally tested per the instructions for use (ifu) provided with this kit, which states "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was inserted through a laboratory ars/18ga introducer needle subassembly and the guide wire was able to pass with little to no difficulty.Functional analysis could not be performed on the needle as it was not returned, and an introducer needle is not part of the reported finished good.A manual tug test confirmed that both the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with the kit warns the user , "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished , radiographic visualization should be obtained and further consultation requested." the customer report of a kinked guide wire was confirmed through examination of the returned sample.Visual examination revealed there were two kinks towards the distal end of the guide wire.The introducer needle reported as part of the event was not returned.The returned guide wire did not match dimensional specifications of the guide wire provided in the reported finished good which suggests the customer either returned the incorrect guide wire or reported the incorrect finished good.A device history record review was performed on the reported batch, and no relevant findings were identified.Based on these circumstances and the customer description, the root cause could not be determined due to the discrepancy between the reported device and the returned sample.Teleflex will continue to monitor and trend for reports of this nature.Other remarks: n/a corrected data: n/a.

• Brand Name: SPRING WIRE GUIDE COMPONENT
• Common Device Name: CATHETER HEMODIALYSIS IMPLANTE
• 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: 18183429
• Report Number: 9680794-2023-00902
• Device Sequence Number: 15345395
• Product Code: MPB
• UDI-Device Identifier: 10801902122503
• UDI-Public: 10801902122503
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K993933
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/26/2023

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 Catalogue Number: AW-04435
• Device Lot Number: 14F22K0172
• 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: 10/26/2023
• Supplement Date Received by Manufacturer: 12/06/2023
• Initial Report FDA Received Date: 11/21/2023
• Supplement Report FDA Received Date: 12/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/24/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown