MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number	IPN916441
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "we had an incident/near miss again with a central line 20 cm, the doctor was inserting the line, when he was trying to remove the guidewire it near break, luckily that didn't happen and no harm to the patient." additional information received states the user "was able to feed the catheter through but noted this kink on removal of the guide".Another attempt was done and completed successfully.Further information received states there was damage to both the guide wire and the dilator.It was reported "the shaft of the dilator was kinked".There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 3006425876-2025-00495 and 3006425876-2025-00472.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "we had an incident/near miss again with a central line 20 cm, the doctor was inserting the line, when he was trying to remove the guidewire it near break, luckily that didn't happen and no harm to the patient." additional information received states the user "was able to feed the catheter through but noted this kink on removal of the guide".Another attempt was done and completed successfully.Further information received states there was damage to both the guide wire and the dilator.It was reported "the shaft of the dilator was kinked".There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr numbers include: 3006425876-2025-00495 and 3006425876-2025-00472.
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of a kinked guidewire was able to be confirmed by the photos, which show a guidewire with a significant kink in its body.Definite signs of use were observed.However, a complete visual inspection to determine the cause of the damage could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns 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." without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 20CM
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: 22018506
• Report Number: 3006425876-2025-00472
• Device Sequence Number: 8778888
• Product Code: FOZ
• UDI-Device Identifier: 10801902029413
• UDI-Public: (01)10801902029413(11)250122(17)261213(10)71F25A0201(21)
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2025

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: IPN916441
• Device Catalogue Number: CV-25854
• Device Lot Number: 71F25A0201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/30/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/22/2025
• 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