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	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "(b)(6) 2026, the doctor open the package and found the swg kinked prior to the patient." the user changed to a new set to complete the procedure.
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire assembly for analysis, along with the following associated components: 5 cc arrow raulerson syringe, 18 ga introducer needle, dilator, and 2-lumen 7 fr catheter.The guide wire straightener tube was returned with the other components but was not connected to the guidewire assembly.No definitive signs of use were observed on the guidewire or the other returned components.Visual inspection identified three kinks in the guidewire.Two kinks were observed toward the distal end, including one located in the portion of the guidewire that passes into the guidewire advancer assembly.The third kink was located in the j-bend region.Microscopic examination confirmed the observed kinks and identified a misaligned coil along the j-bend curve at the same location.Both the distal and proximal welds were present and appeared full and spherical.Three kinks on the guide wire located at 497mm, 559mm, and 590mm from the proximal weld.The overall length of the guide wire measured 602mm, which is within the specification of 596mm-604mm per product drawing.The outer diameter (od) of the guide wire measured 0.790mm, which is within the specification of 0.788-0.826mm per guide wire product drawing.Functional inspection of the guide wire was performed per the instructions for use (ifu) provided with the kit which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." resistance was encountered when the kinked portion of the guidewire passed through the returned arrow raulerson syringe (ars)/18 ga introducer needle subassembly.Minor force was applied at one kinked location to advance the guidewire.All undamaged sections of the guidewire passed through the returned ars/18 ga introducer needle subassembly without resistance.A manual tug test confirmed the distal and proximal welds were secure and 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 withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire".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 customer-reported kinked guidewire was confirmed during evaluation of the returned sample.Visual inspection identified three kinks in the guidewire, including two toward the distal end, one of which was located in the portion of the guidewire that passes into the guidewire advancer assembly.A third kink was identified in the j-bend region.The guidewire straightener tube was returned with the other components but was not connected to the returned guidewire assembly.The guidewire met all relevant dimensional and functional requirements.No manufacturing-related defects or anomalies were identified in the returned guidewire during the investigation, and a device history record review did not identify any manufacturing related issues.Based on the customer report and sample received, the potential root cannot be determined as it cannot be confirmed when the damage occurred.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that "on (b)(6) 2026, the doctor open the package and found the swg kinked prior to the patient.".The user changed to a new set to complete the procedure.

• 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: 24803784
• Report Number: 3006425876-2026-00386
• Device Sequence Number: 10707607
• Product Code: FOZ
• UDI-Device Identifier: 10801902217551
• UDI-Public: (01)10801902217551(11)250303(17)270130(10)71F25B1204(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
• Report Date (Section B): 03/16/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: CS-27702-E
• Device Lot Number: 71F25B1204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 04/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/03/2025
• 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