MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-14402
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	12/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "according to the reported information, the patient was in the operating room for a cvc insertion.During the procedure, it was reported that the guidewire became stuck and could not be removed from the catheter.A loss of integrity was observed, making it impossible to withdraw the set (catheter and guidewire)".A chest xray showed intravascular guidewire retention.The patient was transferred for extraction vis pediatric cardiac catheterization.The attempt to remove the device was unsuccessful.An attempt was done to remove the catheter via vascular surgery and pediatric cardiac surgery, which failed due to evidence of thrombosis.The patient's current condition is reported as "stable".Associate mdr numbers include: 9680794-2026-00272.
Event or Problem Description
It was reported that "according to the reported information, the patient was in the operating room for a cvc insertion.During the procedure, it was reported that the guidewire became stuck and could not be removed from the catheter.A loss of integrity was observed, making it impossible to withdraw the set (catheter and guidewire)".Additional information received states "a puncture of the right subclavian vein is perfromed with venous return acheieved on the second attempt.Using the seldinger technique the guidwire is advanced resulting in multiple kinks that prevent further advancement.The guidewire is withdrawn.A puncture of the left subclaviein vein is perfromed, with venous returned achieved on the first attempt.Using the seldinger technique, the guidewire is advanced without difficulty.A central venous catherter is inserted but cannot be advanced.An attempt is made to remove the guidwire but it can not be extracted.Loss of consistency and stability (fraying) of the guidewire is observed with a fracture.A chest xray is perfromed, showing the catheter guidewire with loops within the vascular tract." the patient was transferred for extraction vis pediatric cardiac catheterization.The attempt to remove the device was unsuccessful.An attempt was done to remove the catheter via vascular surgery and pediatric cardiac surgery, which failed due to evidence of thrombosis.The patient's current condition is reported as "stable".Associate mdr numbers include: 9680794-2026-00206 and 9680794-2026-00272.
Additional Manufacturer Narrative
(b)(4) the actual device was not returned; however, the customer provided two photos for analysis.Clinical and medical affairs (cma) was consulted and confirmed the photos show a knotted guidewire in the left subclavian vein followed by the guidewire loose in the patient's vasculature.The complaint of a knotted guidewire was able to be confirmed by the photos.Clinical and medical affairs (cma) was consulted and stated that, "this is complex as the patient had a history of thrombosis and the wire appears to be clinician error due to coil.This normally results from advancing the wire with resistance due to obstruction or vessel occlusion.The wire appears to have met an obstruction and coiled on itself.Also note due to the patient extensive history the wire was unable to be removed during interventional attempt." additional information from the customer stated that the patient underwent vascular surgery for removal of the guidewire; however, due to severe chronic fibrosis, removal of the foreign body was not feasible, so closure of the vena cava was performed via angioplasty with a venous patch.The patient is reportedly in a stable condition.Therapeutic anticoagulation was initiated and will be administered for a minimum of 6 weeks, with a repeat angiogram in 6 weeks to assess continuity for up to 3 months.Additionally, the customer stated that at this time, it is still under investigation, but renal and iliac vein thrombosis with severe fibrosis cannot be ruled out as a possible cause.A device history record review was performed, and no relevant findings were identified.The instructions for use (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." the customer report of guidewire knotting within the patient was confirmed through investigation of the customer provided photos and consultation with clinical and medical affairs (cma).The provided x-ray images show the guidewire within the left subclavian vein knotted and loose within the patient vasculature.A device history record review was performed, and no relevant findings were identified to suggest a manufacturing issue.Based on the customer photos and consultation with cma, unintentional use error (clinician technique) likely caused or contributed to the reported event; however, the root cause cannot be determined without the sample received.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 CM
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24673864
• Report Number: 9680794-2026-00206
• Device Sequence Number: 10285058
• Product Code: OWL
• UDI-Device Identifier: 00801902102140
• UDI-Public: (01)00801902102140(11)241104(17)281130(10)14F24L0004(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 03/02/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: CS-14402
• Device Lot Number: 14F24L0004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 03/24/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2024
• 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 Age: 12 MO
• Patient Sex: Male