MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 3-LUMEN 7 FR X 8"; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN037247
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported when the vessel was dilated with the needle, the chief inserted the guidewire and met some resistance.She attempted to remove the guidewire and it appeared to get caught on the needle.She removed the needle and guidewire together.When the device was outside the patient, she again tried to remove the guidewire, meeting resistance and then the guidewire shredded.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported when the vessel was dilated with the needle, the chief inserted the guidewire and met some resistance.She attempted to remove the guidewire and it appeared to get caught on the needle.She removed the needle and guidewire together.When the device was outside the patient, she again tried to remove the guidewire, meeting resistance and then the guidewire shredded.No patient harm reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).The customer returned one guidewire inserted through an introducer needle.Signs of use in the form of biological material were observed on both components.The guide wire was removed from the introducer needle with moderate force.Large amounts of biological material were also removed.Visual analysis revealed the guide wire had unraveled from the distal end.The guide wire also contained two minor bends in its body.Microscopic examination revealed that the core wire separated directly adjacent to the distal weld.The proximal weld was intact and appeared spherical.The returned introducer needle shows evidence of use but no obvious defects or anomalies.The bends in the guide wire measured 15 mm and 445 mm from the proximal weld.The core wire length measured 602 mm, which is within the specification limits of 596-604 mm per the guide wire graphic, indicating no part of the guide wire was missing.The guide wire outer diameter measured 0.794 mm, which is within the specification limits of 0.788-0.826 mm per the guide wire graphic.The cannula outer diameter measured 0.04990", which is within the specification limits of 0.0495"-0.0505" per the cannula graphic.The cannula inner diameter measured 0.041", which is within the specification limits of 0.041"-0.043" per the cannula graphic.The returned guide wire and needle were functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the undamaged portions of the guide wire were passed through a lab inventory ars and the returned needle with minimal resistance.A manual tug test confirmed the proximal weld was fully secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with this 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.Do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the report that the guide wire unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the distal weld.The guide wire and introducer needle 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 caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC KIT: 3-LUMEN 7 FR X 8"
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 16279638
• Report Number: 9680794-2023-00026
• Device Sequence Number: 6522196
• Product Code: FOZ
• UDI-Device Identifier: 10801902113143
• UDI-Public: 10801902113143
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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: 04/26/2024
• Device Model Number: IPN037247
• Device Catalogue Number: ASK-45703-PYNH
• Device Lot Number: 13F22G0594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2023
• Supplement Date Received by Manufacturer: 02/23/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 02/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2022
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown