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	03/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "on (b)(6) 2026, in emergency internal medicine, during the insertion, the swg was found kinked during use on the patient." the user changed to a new set to complete the procedure.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn(b)(4).The customer provided one photo for analysis.The image shows the guidewire partially advanced from the guidewire assembly and multiple kinks observed proximal to the distal j-bend.The complaint of a kinked guidewire was able to be confirmed by the photo.The customer returned one guidewire for evaluation.The guidewire was returned within the advancer tube and showed evidence of use.The guidewire was observed to have one kink towards the distal end of the body.The distal j-bend was slightly misshapen but intact.Microscopic examination confirmed the kink in the guide wire body.Both welds were present and were observed to be full and spherical.The kink in the guidewire was located 21mm from the distal tip.The overall length of the guidewire measured 457 mm which is not within the specification of 596-604 mm per guidewire product drawing; which indicates that the customer either returned the incorrect device or reported the incorrect material number.The outer diameter of the guidewire measured 0.800 mm which is within the specification of 0.788-0.826 mm per guidewire product drawing.The guidewire was functionally tested per the product instructions for use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guidewire was passed through lab an inventory arrow raulerson syringe (ars) and introducer needle.Resistance was encountered due to the kink in the guidewire.The undamaged portion of the guidewire was able to pass with little to no resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit instructs 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 report that the guidewire kinked during use was confirmed through examination of the returned sample and customer supplied photo.The guidewire was kinked 21mm from the distal tip.The returned guidewire did not meet the dimensional requirements of the guidewire included in the reported kit which indicates that the customer either returned the incorrect device or reported the incorrect material number.A device history record review performed on the reported batch did not identify any manufacturing related issues.Based on the discrepancy between the reported material number and the returned device, the root cause of complaint investigation cannot be determined.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "1(b)(6) 2026, in emergency internal medicine, during the insertion, the swg was found kinked during use on the patient." the user changed to a new set to complete the procedure.There was no patient harm or injury.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: 24815689
• Report Number: 3006425876-2026-00388
• Device Sequence Number: 14988927
• Product Code: FOZ
• UDI-Device Identifier: 10801902217551
• UDI-Public: (01)10801902217551(11)250312(17)270217(10)71F25C0279(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): 03/17/2026

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: CS-27702-E
• Device Lot Number: 71F25C0279
• 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: 03/17/2026
• Supplement Date Received by Manufacturer: 04/21/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/12/2025
• 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