MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 3 LUMEN 12 FR X 6IN; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	ASK-22123-UAB
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4),.
Event or Problem Description
It was reported "wire frayed".The patient's current condition is reported as "unknown".Additional information was requested from the customer; however, further details have not been provided at this time.
Event or Problem Description
It was reported "wire frayed".The patient's current condition is reported as "unknown".Additional information was requested from the customer; however, further details have not been provided at this time.
Additional Manufacturer Narrative
(b)(4) the customer provided one image for analysis.The image shows the lidstock of the finished good associated with this complaint.The customer also returned a 3-lumen cvc, guidewire, and lidstock for analysis.The guidewire and the catheter will be analyzed as part of this complaint.It was observed that the guidewire was returned inserted through the catheter body.Signs of use in the form of biological material were observed inside the catheter body.Visual examination revealed that the guidewire is unraveled from the distal end and has multiple kinks along the body.It was noted that the proximal end of the guidewire was inserted through the catheter first, which implies the device was not used according to the ifu provided with this kit.Microscopic examination of the guidewire confirmed the damage and revealed that the core wire was broken adjacent to the distal weld.Both welds were present and appeared full and spherical.Visual and microscopic examination of the catheter revealed kinking that was consistent with the location of the kinking of the guidewire.The major kinks in the guidewire body measured 286mm, 308mm, 341mm, 352mm, 370mm, and 521mm from the proximal weld.The total length of the broken core wire measured 603mm, which is within the specification of 596mm - 604mm per the guidewire product drawing.The outer diameter of the guidewire measured 0.84mm , which is within the outer diameter specification of 0.838mm - 0.877mm per the guidewire product drawing.The kinks in the catheter body measured 47mm, 103mm, and 120mm from the juncture hub.The catheter body length measured 165mm , which is within the specification of 157mm -177mm per the catheter product drawing.The catheter body outer diameter measured 3.98mm, which is within the specification limits of 3.96mm - 4.06mm per the catheter extrusion product drawing.The damaged guidewire was manually removed from the catheter to perform functional testing.Resistance was met at the locations of the kinks when separating the components.Next, a lab inventory guidewire of the same diameter was inserted through the returned catheter.No resistance was encountered as the guidewire passed completely through the catheter.Performed per ifu statement, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire." functional testing of the returned guidewire could not be performed due to the damage.A manual tug test revealed that the core wire was secure to the proximal weld.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs 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 ifu also states, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the report that the guidewire unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the distal weld.The guidewire and catheter met all relevant dimensional and functional requirements during investigation testing.No manufacturing defects were found during this investigation.Arrow guidewires 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.Guidewire 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 12 FR X 6IN
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 22309524
• Report Number: 9680794-2025-00528
• Device Sequence Number: 18127046
• Product Code: FOZ
• UDI-Device Identifier: 10801902144956
• UDI-Public: (01)10801902144956(11)241107(17)260624(10)33F24F0854(21)
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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: 06/24/2026
• Device Catalogue Number: ASK-22123-UAB
• Device Lot Number: 33F24F0854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2024
• 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; NOT REPORTED
• Patient Sex: Unknown