MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-27702-E
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "during insertion, the swg was found easy to kink, the resistance was found when the swg inserted into ars." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).
Additional Manufacturer Narrative
(b)(4) the customer provided one photo for analysis.The photo shows the guidewire within the advancer assembly.No defects or anomalies were observed on the component pictured.The customer also returned one opened cvc kit including the guidewire within the arrow advancer, two-lumen catheter, catheter-over-needle, 18 ga introducer needle, arrow raulerson syringe (ars), transduction probe, and dilator.The guidewire, ars, and introducer needle were analyzed for this complaint investigation.Signs of use in the form of biological material were observed on the guidewire.A misshapen j-bend bend, three bends, and one kink were observed on the guidewire.Microscopic examination confirmed that both the distal and proximal welds were spherical and intact.No other defects or anomalies were observed on the returned components.The bends in the guidewire measured 32 mm, 413 mm, and 519 mm from the proximal end.The kink in the guidewire measured 35 mm from the distal end.The overall length of the guidewire measured 601 mm, which is within the specification limits of 596 mm - 604 mm per guidewire product drawing.The outer diameter of the guidewire measured 0.800 mm which is within the specification limits of 0.788 mm - 0.826 mm per guidewire product drawing.The inner diameter of the introducer needle measured 0.042", which is within the specification limits of 0.041" - 0.043" per needle cannula product drawing.The guidewire was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guidewire was advanced through the returned ars with and without the returned 18 ga introducer needle attached.The guidewire passed with little to no resistance.A manual tug test confirmed both the distal and proximal welds of the guidewire were intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with this product informs the user, "advancement of guidewire through arrow raulerson syringe may require a gentle twisting motion," and " warning: do not apply undue force on guidewire to reduce risk of possible breakage." the customer report of guidewire/ars resistance was not confirmed by complaint investigation.A device history record review was performed, and no relevant findings were identified.Visual examination revealed a misshapen j-bend bend, three bends, and one kink on the guidewire; however, the guidewire, ars, and introducer needle met all relevant dimensional and functional requirements.Based on these circumstances and the customer description, 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 "during insertion, the swg was found easy to kink, the resistance was found when the swg inserted into ars." the user changed to a new set to resolve the issue.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23334770
• Report Number: 3006425876-2025-00953
• Device Sequence Number: 18784829
• Product Code: FOZ
• UDI-Device Identifier: 00801902102362
• UDI-Public: (01)00801902102362(11)240917(17)260821(10)71F24J0624(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2025

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: 08/21/2026
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F24J0624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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