MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CV-17702-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "(b)(6) 2026, the swg was found kinked during insertion into 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".
Event or Problem Description
It was reported that "(b)(6) 2026, the swg was found kinked during insertion into 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).The customer returned one guidewire inserted through the distal lumen of a 2-lumen cvc.Definite signs of use in the form of biological material were observed.Upon removal, the guidewire was observed to be unraveled from the proximal end.Kinking was also visible along the guidewire body and the distal j-bend appeared misshapen.Additionally, two kinks were observed along the catheter body.Microscopic examination of the guidewire confirmed the core wire was broken adjacent to the proximal weld.Both welds were present and appeared full and spherical.The major kinks in the guidewire body measured 80mm, 340mm, 364mm, 387mm, 487mm, 525mm, and 570mm from the proximal end of the core wire.The broken core wire measured 600mm in length, which is within the specification of 596mm - 604mm per the guidewire product drawing; therefore, no pieces of the core wire appear to be missing.The outside diameter of the guidewire measured 0.80mm, which is within the outer diameter specification of 0.788mm - 0.826mmmm per the guidewire product drawing.The catheter was kinked 55mm and 154mm from the juncture hub.The catheter body length measured 215mm, which is within the specification of 207mm - 227mm per the catheter product drawing.The catheter body outer diameter measured 2.38mm, which is within the specification limits of 2.36mm - 2.46mm per the catheter extrusion product drawing.After removal of the guidewire from the catheter, a lab inventory guidewire (outer diameter measured 0.80mm) was passed through the distal extension line and catheter body.Resistance was encountered at the location of the kinks.Additionally, biological material was observed exiting the distal lumen.Performed per ifu statement, "thread tip of catheter over guidewire".The returned guidewire was not able to be functionally tested due to the damage and unraveling.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 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 ifu also states, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The report of a kinked guidewire was confirmed through examination of the returned sample.The guidewire was kinked in multiple locations and unraveled from the proximal end.Additionally, the core wire was broken adjacent to the proximal weld.The guidewire and catheter met all dimensional requirements and functional during investigation testing.No manufacturing defects were found during this investigation.Arrow guidewires 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 guidewire kinking.Guidewire 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.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 24545811
• Report Number: 3006425876-2026-00258
• Device Sequence Number: 14884235
• Product Code: DQY
• UDI-Device Identifier: 10801902183771
• UDI-Public: (01)10801902183771(11)240524(17)290430(10)71F24E0903(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2026

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-17702-E
• Device Lot Number: 71F24E0903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Supplement Date Received by Manufacturer: 03/23/2026
• Initial Report FDA Received Date: 03/09/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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