MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC AROW MULTI-LUMEN/PSI KIT; INTRODUCER CATHETER

Catalog Number	AK-21142-SK
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire, a dilator, and the product lidstock for analysis.The guide wire was advanced through the dilator was unraveled.The components showed evidence of use in the form of dried blood.Visual examination revealed the guide wire was unraveled from the distal weld and is kinked/distorted towards the distal end of the body.The core wire distal j-bend was deformed and exposed out of the coil wire.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the distal weld.The exposed distal core wire tip was tapered at the point of separation.Both welds were present and appeared full and spherical.Examination of the dilator did not reveal any defects or anomalies.The major kinks in the guide wire body were measured at 40 mm and 72 mm from the distal tip.The broken core wire measured 455 mm in length, which is within the specification limits of 450-458 mm per guide wire product drawing; therefore, no pieces of the core wire appear to be missing.The outer diameter of the guide wire measured 0.838 mm, which is within the specification limits of 0.838-0.877 mm per guide wire product drawing.The dilator length from the distal end of the juncture hub to the distal tip measured 8 2/16" which is within the specification limits of 8 1/32"-8 9/32" per dilator product drawing.The distal tip of the dilator measured 0.036", which is within the specification limits of 0.036"-0.038" per dilator product drawing.Functional inspection of the guide wire could not be performed for this complaint investigation due to the damage to the returned guide wire.Simulated use of the dilator was performed per the instructions-for-use (ifu).A lab inventory 0.035" guide wire (measured 0.846 mm) was threaded through the returned dilator and was able to advance through with little to no resistance.A manual tug test confirmed that the proximal weld was intact.A device history record review was performed, and no relevant findings were identified.The instructions-for-use (ifu) provided with this product warns the user , "do not apply excessive force in placing or removing guidewire, dilator, or access device.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 report that the guide wire unraveled was confirmed through complaint investigation of the returned sample.The core wire was broken adjacent to the distal weld.The guide wire and dilator met all functional/ dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "the internal wire had come out of the coiled external wire with coil still in tact.There was no reported patient harm or consequence.".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that: "the internal wire had come out of the coiled external wire with coil still intact.There was no reported patient harm or consequence.".

• Brand Name: AROW MULTI-LUMEN/PSI KIT
• Common Device Name: INTRODUCER CATHETER
• 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: 20342141
• Report Number: 9680794-2024-00966
• Device Sequence Number: 8107977
• Product Code: DYB
• UDI-Device Identifier: 30801902122248
• UDI-Public: (01)30801902122248(11)230502(17)250307(10)33F23D0241(21)
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• 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): 09/06/2024

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: 03/07/2025
• Device Catalogue Number: AK-21142-SK
• Device Lot Number: 33F23D0241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 10/04/2024
• Initial Report FDA Received Date: 10/01/2024
• Supplement Report FDA Received Date: 10/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2023
• 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