MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 4FR X 13CM; CATHETER, PERCUTANEOUS

Model Number	IPN918478
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "during insertion, when they retracted the guidewire, it was kinked.They opened a second cvc and had the same problem.It was hard to remove the guidewire." the device was removed and replaced.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 3006425876-2025-00486 and 3006425876-2025-00440.
Event or Problem Description
It was reported "during insertion, when they retracted the guidewire, it was kinked.They opened a second cvc and had the same problem.It was hard to remove the guidewire." the device was removed and replaced.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 3006425876-2025-00486 and 3006425876-2025-00440.
Additional Manufacturer Narrative
(b)(4).The customer returned a single guidewire and an empty kit with its product lidstock for evaluation.The catheter involved in this complaint was not returned.Visual analysis revealed three major kinks across the guidewire.Microscopic examination confirmed the damage and revealed that the distal j-bend was misshapen.Microscopic examination also revealed that the distal and proximal welds were observed to be full and spherical.The major kinks on the guidewire measured 74mm, 231mm, and 433mm from the proximal weld.The guidewire total length measured 456mm, which is within the specification limits of 449.2mm - 458.8mm per the guidewire product drawing.The guidewire outer diameter measured 0.44mm, which is within the specification limits of 0.432mm - 0.457mm per the guidewire product drawing.The guidewire was functionally tested per the instructions for use (ifu) provided with this kit, which instructs the user, "thread tip of catheter over guidewire.Sufficient guidewire length must remain exposed at hub end of catheter to maintain a firm grip on guidewire." the guidewire was threaded through a lab inventory 21ga introducer needle/arrow raulerson syringe (ars) subassembly as well as through a lab inventory catheter.The guidewire passed through all the components with little to no resistance at the undamaged portions.Major resistance was encountered at the locations of the kinks.A manual tug test confirmed that 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 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 analysis of the returned sample.Visual analysis revealed three major kinks on the guidewire.Despite the damage, the guidewire met all relevant dimensional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, the report is consistent with damage due to unintentional use error; however , without the catheter also returned for analysis, the root cause cannot be determined at this time.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 4FR X 13CM
• 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: 21977643
• Report Number: 3006425876-2025-00486
• Device Sequence Number: 9188748
• Product Code: DQY
• UDI-Device Identifier: 00801902000415
• UDI-Public: (01)00801902000415(11)230225(17)271231(10)71F23E1279(21)
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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 Model Number: IPN918478
• Device Catalogue Number: CS-14403
• Device Lot Number: 71F23E1279
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2023
• 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