MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW SAC KIT: 18 GA X 16CM; CATHETER PERCUTANEOUS

Catalog Number	SAC-01618-X1A
Medical Device Problem Codes	Material Disintegration (1177); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "during placement of an arterial catheter today and when the provider inserted the guidewire, the wire would not retract and when she pulled the entire wire and needle out, the wire appeared to disintegrate and come apart.She noted no issues with the wire or potential shearing during insertion." a new catheter was placed in a different site.There was no patient harm or injury.The patient's current condition is reported as "critically ill".
Additional Manufacturer Narrative
(b)(4).The customer provided three photos for analysis.The photos show an unraveled guide wire and an introducer needle.The customer also returned one guide wire, an 18ga introducer needle, and the product lidstock for analysis.The guide wire was advanced through the introducer needle and was unraveled towards the distal end.Signs of use in the form of biological material were observed on and within the returned components.Visual analysis revealed the guide wire was unraveled towards the distal end.Dried biological material was observed on the guide wire and within the introducer needle when the guide wire was removed.Microscopic analysis of the guide wire confirmed the core wire was broken adjacent to the distal weld.The exposed distal core wire tip was tapered and discolored at the point of separation.Both welds were present and appeared full and spherical.No defects or anomalies were observed on the introducer needle.The broken core wire measured 436 mm and 20 mm in length, totaling 456 mm, 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 outside diameter of the guide wire measured 0.621 mm, which is within the specification limits of 0.610-0.635 mm per guide wire product drawing.The inner diameter of the needle cannula measured 0.0410", which is within the specification limits of 0.0410"-0.0430" per needle cannula product drawing.Undue force was used to remove the guide wire from the introducer needle and the guide wire coil wire separated.The guide wire and introducer needle were functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "insert tip of guidewire through introducer needle into artery (until depth-marking [if provided] on wire enters hub of needle)." the returned guide wire was advanced through the returned introducer needle, and the undamaged portions of the guide wire advanced through with little to no resistance.A manual tug test confirmed the proximal weld was intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "warning: to reduce the risk of guidewire damage, do not retract guidewire against edge of needle while in vessel." the report of a guide wire/needle resistance with an unraveled guide wire was confirmed through complaint investigation of the returned sample.Visual and functional analysis revealed that the guide wire was unraveled and met resistance due to a build-up of biological material inside the needle.The guide wire and needle met all relevant dimensional and functional requirements.A device history record review did not identify any manufacturing related issues.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.0- or 2.75-pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 1.1 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 damage.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances and the customer description that the damage was observed during use, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW SAC KIT: 18 GA X 16CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21920153
• Report Number: 9680794-2025-00342
• Device Sequence Number: 9086917
• Product Code: DQY
• UDI-Device Identifier: 10801902145489
• UDI-Public: (01)10801902145489(11)241211(17)260731(10)33F24J0144(21)
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K171146
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/02/2025

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
• Device Expiration Date: 07/31/2026
• Device Catalogue Number: SAC-01618-X1A
• Device Lot Number: 33F24J0144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/02/2025
• Initial Report FDA Received Date: 04/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2024
• 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
• Patient Sex: Unknown