MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 8 FR X 20 CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CS-25802-E
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported that "when attempted to remove the guidewire from the 2-way cvc, resistance was encountered.Upon removal, the kinks were found on the wire".The patient is harm and had no harm or injury.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one guidewire, advancer, dilator, and transduction probe within an opened cvc kit for evaluation.The catheter was not returned for analysis.Visual analysis of the guidewire revealed kinks and bends throughout the body.Microscopic analysis showed the j-bend was misshapen but both proximal and distal welds were full and spherical.Visual analysis of the catheter could not be performed as it was not returned for analysis.Kinks in the guidewire were measured at 512mm and 579mm , from the proximal end.A continuous bend started at 24mm, from the proximal end.The guidewire length measured 601mm which is within the specification of 596mm - 604mm per 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.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 18ga 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.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 this 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 customer report of a kinked guidewire was confirmed based on the returned sample.However, the catheter associated with this complaint was not returned.The returned guidewire passed all relevant visual , dimensional, and functional requirements, and a device history record review revealed no relevant findings.Based on the customer report and the sample received, the potential root cause cannot be confirmed at this time without the catheter returned.Teleflex will continue to monitor and trend on reports of this nature.
Event or Problem Description
It was reported that "when attempted to remove the guidewire from the 2-way cvc, resistance was encountered.Upon removal, the kinks were found on the wire".The patient is harm and had no harm or injury.

• Brand Name: ARROW CVC SET: 2-LUMEN 8 FR X 20 CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 21273073
• Report Number: 3006425876-2025-00080
• Device Sequence Number: 3916562
• Product Code: FOZ
• UDI-Device Identifier: 00801902102331
• UDI-Public: (01)00801902102331(11)231128(17)251031(10)71F23L1245(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K900263
• 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): 01/13/2025

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 Expiration Date: 10/31/2025
• Device Catalogue Number: CS-25802-E
• Device Lot Number: 71F23L1245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 02/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• 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