MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 5 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	ES-04301
Medical Device Problem Codes	Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "on (b)(6) 2025, the doctor from the intensive care unit (icu) reported that the guidewire became kinked and the resistance was found during catheterization.They changed to a new one." 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 within its assembly and an arrow raulerson syringe (ars) for analysis.Signs of use were observed on and within the returned components.Visual inspection of the guidewire revealed three kinks throughout the body.The distal j-bend was also misshapen.Microscopic examination confirmed the damage.Both welds were present and appeared to be full and spherical.The damage to the returned sample matched the customer description of the guidewire becoming kinked and encountering resistance during catheterization.Visual inspection of the ars revealed no obvious defects or anomalies.The kinks on the guidewire measured 350mm, 369mm, and 570mm from the proximal end.The guidewire total length measured 599mm, which is within the specification limits of 596mm - 604mm per the guidewire product drawing.The guidewire outer diameter measured 0.80mm, which is within the specification limits of 0.788mm - 0.826mm per the guidewire product drawing.Functional inspection of the guidewire was performed per the product instructions for use (ifu), which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guidewire was inserted through the returned ars and lab inventory 18ga introducer needle.It was able to advance with no resistance at the undamaged portion.Major resistance was encountered at the locations of the kinks.A manual tug test confirmed the distal and proximal welds were 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.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 of a kinked guidewire was confirmed through investigation of the returned sample.Visual inspection revealed three kinks throughout the guidewire body.Despite this, the guidewire and ars met all relevant dimensional and functional requirements.A device history record review was performed with no relevant findings.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported that "on (b)(6) 2025, the doctor from the intensive care unit (icu) reported that the guidewire became kinked and the resistance was found during catheterization.They changed to a new one." 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: 5 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: 24133396
• Report Number: 3006425876-2026-00047
• Device Sequence Number: 10399839
• Product Code: DQY
• UDI-Device Identifier: 10801902122756
• UDI-Public: (01)10801902122756(11)230201(17)280131(10)71F23A2035(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): 12/26/2025

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 Catalogue Number: ES-04301
• Device Lot Number: 71F23A2035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2025
• Supplement Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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