MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 8 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-15402-E
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "during cvc insertion, a guidewire defect was evident in three sets.Two 4-fr cvcs and one 5-fr cvc were ultimately used.This prolonged the operative time." there was a deformity in the distal part of the guide.This prolonged the procedure.There was no medical intervention required.The patient's current condition is reported as "hospitalized".Associated mdr number includes: 9680794-2025-00959, 9680794-2025-00961, and 9680794-2025-00960.
Event or Problem Description
It was reported that: "during cvc insertion, a guidewire defect was evident in three sets.Two 4-fr cvcs and one 5-fr cvc were ultimately used.This prolonged the operative time." there was a deformity in the distal part of the guide.This prolonged the procedure.There was no medical intervention required.The patient's current condition is reported as "hospitalized".Associated mdr number includes: 9680794-2025-00959, 9680794-2025-00961, and 9680794-2025-00960.
Additional Manufacturer Narrative
Qn# (b)(4).The actual device was not returned; however, the customer provided three photos and a video for analysis.The images show a non-arrow lidstock and a cvc kit with an unraveled guidewire.The complaint of a damaged guidewire was able to be confirmed by the photos as the images and video show a used guidewire with evidence of unraveling, however, a complete visual inspection to evaluate 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." the customer report of a damaged guidewire was confirmed by visual inspection of the customer supplied photos and video.The images and video show a used guidewire with evidence of unraveling, however, full complaint verification testing to evaluate 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.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.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 8 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: 23582674
• Report Number: 9680794-2025-00961
• Device Sequence Number: 9398281
• Product Code: DQY
• UDI-Device Identifier: 10801902099645
• UDI-Public: (01)10801902099645(11)240920(17)280630(10)14F24J0133(21)
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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 Catalogue Number: CS-15402-E
• Device Lot Number: 14F24J0133
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 12/10/2025
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2024
• 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