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

Catalog Number	CV-25703-E
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "a triple-lumen central venous catheter, involving an oncology patient in whom the first step of guidewire and catheter placement was performed.At the time of guidewire removal, the attending physician observed an abnormality, noting a frayed appearance, although the guidewire was removed in its entirety.Subsequently, a second attempt was made to place the catheter and guidewire using the seldinger technique; during the removal of the guidewire, the same fraying phenomenon occurred, with the particularity that the guidewire became lodged in the patient's access site.As a result, the patient required surgical intervention for device removal." the patient's current condition is reported as "deceased".It was reported "the device did not potentially contribute to the patients death".Associated mdr numbers include: 3006425876-2026-00088.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided three photos for analysis.The photos show the guide wire unraveled, and the distal end of the core wire appeared broken and protruding out of the coil wire.Although unraveling is observed, it cannot be confirmed from the photos alone whether the guidewire is separated in any location.A complete visual inspection to determine the cause of the damage could not be performed as no sample was returned for analysis.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.Warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." 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.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "a triple-lumen central venous catheter, involving an oncology patient in whom the first step of guidewire and catheter placement was performed.At the time of guidewire removal, the attending physician observed an abnormality, noting a frayed appearance, although the guidewire was removed in its entirety.Subsequently, a second attempt was made to place the catheter and guidewire using the seldinger technique; during the removal of the guidewire, the same fraying phenomenon occurred, with the particularity that the guidewire became lodged in the patient's access site.As a result, the patient required surgical intervention for device removal." the patient's current condition is reported as "deceased".It was reported "the device did not potentially contribute to the patients death".Associated mdr numbers include: 3006425876-2026-00082 and 3006425876-2026-00088.

• Brand Name: ARROW VC SET: 3-LUMEN 7FR X 20CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 24257225
• Report Number: 3006425876-2026-00082
• Device Sequence Number: 8309821
• Product Code: FOZ
• UDI-Device Identifier: 10801902029390
• UDI-Public: (01)10801902029390(11)250401(17)270306(10)71F25C0977(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 01/08/2026

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: CV-25703-E
• Device Lot Number: 71F25C0977
• 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: 01/08/2026
• Supplement Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2025
• 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 Age: 74 YR
• Patient Sex: Female