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 Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "(b)(6)2025, the doctor performed deep vein puncture and catheterization for the patient.Before catheterization, when checking the performance of the catheter, the doctor found that the guide wire was broken and displaced at the bend, so the puncture could not be carried out, so he could only replace a new catheter for puncture." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and 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 "on (b)(6) 2025, the doctor performed deep vein puncture and catheterization for the patient.Before catheterization, when checking the performance of the catheter, the doctor found that the guide wire was broken and displaced at the bend, so the puncture could not be carried out, so he could only replace a new catheter for puncture." there was no medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened cvc kit for analysis.Signs of use in the form of biological material were observed inside the guide wire tubing.Visual examination revealed the guide wire is unraveled and separated towards the proximal weld.Kinking was also observed, which resulted in the distal j-bend to be misshapen.Microscopic examination confirmed the damage and revealed that the core wire separated directly adjacent to the proximal weld.The coil wire was also separated.No other defects or anomalies were observed.The major kinks in the guide wire body were measured 21mm, 30mm, 223mm, and 256mm from the distal weld.The broken core wire measured 600mm, which is within the specification of 596mm-604mm per guide wire product.The outside diameter of the guide wire measured 0.800mm, which is within the specification of 0.788mm-0.826mmmm per guide wire product drawing.Functional analysis could not be performed due to the nature of the damage.A manual tug test confirmed that the distal weld was intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The ifu also states, "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 report that the guide wire separated was confirmed through examination of the returned sample.The core wire was broken adjacent to the proximal weld.The guide wire and catheter met all dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.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 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.Based on these circumstances, unintentional use error 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 "(b)(6) 2025, the doctor performed deep vein puncture and catheterization for the patient.Before catheterization, when checking the performance of the catheter, the doctor found that the guide wire was broken and displaced at the bend, so the puncture could not be carried out, so he could only replace a new catheter for puncture." there was 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: 23476907
• Report Number: 3006425876-2025-01022
• Device Sequence Number: 10252191
• Product Code: FOZ
• UDI-Device Identifier: 00801902102362
• UDI-Public: (01)00801902102362(11)240703(17)260607(10)71F24F1263(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,Followup
• Report Date (Section B): 10/09/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/07/2026
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F24F1263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/09/2025
• Supplement Date Received by Manufacturer: 11/25/2025; 12/12/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/26/2025; 12/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2024
• 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; NOT REPORTED
• Patient Sex: Unknown