MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-25703-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that " guide wire bent".The user changed to a new set to complete the procedure.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one guidewire for analysis.Sign of use was observed on the guidewire.Five kinks were identified on the guidewire body, kinks towards the distal end and the j-band region.The distal j-bend was misshapen.Microscopic examination confirmed that both welds were present and appeared full and spherical.The appearance and design of the returned guidewire do not match that of the guidewire provided in finished good cs-25703-e.Kinks on the guide wire were measured at 15 mm, 22 mm, 324 mm, 630 mm, and 654 mm from the proximal weld.The guidewire length measured 685 mm, which exceeds the specification limit of 596 mm to 604 mm per product drawing.The guidewire outer diameter measured 0.862 mm, which exceeds the specification limit of 0.788 mm-0.826 mm per product drawing.The dimensional discrepancies identified for the returned guidewire indicate that it does not conform to the specifications associated with the reported material number.These indicate that either an incorrect material number was reported or a different product was returned for evaluation.The guidewire was functionally tested in accordance with the product instructions for use (ifu).The ifu provided with this kit instructs the user to "advance the guidewire into the arrow raulerson syringe approximately 10 cm until it passes through the syringe valves or into the introducer needle." functional testing was performed by advancing the guidewire through a laboratory inventory arrow raulerson syringe (ars) and a laboratory inventory 18-gauge introducer needle.Minimal resistance was observed at the kinked locations.The undamaged portions of the guidewire advanced through the ars and introducer needle without resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution, "do not apply excessive force in placing or removing the 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 report of a kinked guidewire was confirmed through visual analysis of the returned sample.The guidewire contained four kinks on the guide wire body, kinks located towards the distal end and the j-bend area.The returned guidewire did not meet all relevant dimensional and functional requirements.The dimensional analysis confirmed the returned sample does not match the customer reported finished good.No manufacturing defects were found during this investigation, and a device history record review did not identify any manufacturing-related issues.Based on the discrepancy between the reported finished good and the returned device, the root cause cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that " guide wire bent".The user changed to a new set to complete the procedure.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: 3-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: 24428771
• Report Number: 3006425876-2026-00203
• Device Sequence Number: 13323087
• Product Code: FOZ
• UDI-Device Identifier: 00801902102324
• UDI-Public: (01)00801902102324(11)250306(17)270213(10)71F25B1185(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K900263
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2026

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 Catalogue Number: CS-25703-E
• Device Lot Number: 71F25B1185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2026
• Supplement Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2025
• 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