MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-14402
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "four attempts are made to place a central venous catheter." additional information received from the customer states the attempts were the "it was indicated in the referred area that the metal guidewire was not advanced, which prevented venous return from being obtained and consequently the central venous catheter was not installed." the customer also states, this was the "probable cause of thrombosis in patient".The catheter was removed and enoxaparin was prescribed every 12 hours.The patient's current condition is reported as "progressing favorably".Associated mdr number includes: 9680794-2025-00318 and 9680794-2025-00325.
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of guidewire difficult to advance in the patient could not be confirmed from the photo alone as it only revealed the insertion site with the catheter advanced into the patient.There was not clear visual evidence of any defect related to difficulty advancing the guidewire from the photo.A device history record review was performed, and no relevant findings were identified.The instructions for use (ifu) provided with this kit states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle.Advancement of guidewire through arrow raulerson syringe may require a gentle twisting motion.If using arrow glidewheel advancer, advance guidewire through the arrow raulerson syringe or through the introducer needle by pushing advancer wheel and guidewire forward.Continue until guidewire reaches desired depth.If using standard arrow advancer, raise thumb and pull arrow advancer approximately 4-8 cm away from arrow raulerson syringe or introducer needle.Lower thumb onto arrow advancer and while maintaining a firm grip on guidewire, push assembly into syringe barrel to further advance guidewire." without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "four attempts are made to place a central venous catheter." additional information received from the customer states the attempts were the "it was indicated in the referred area that the metal guidewire was not advanced, which prevented venous return from being obtained and consequently the central venous catheter was not installed." the customer also states, this was the "probable cause of thrombosis in patient".The catheter was removed and enoxaparin was prescribed every 12 hours.The patient's current condition is reported as "progressing favorably".Associated mdr number includes:9680794-2025-00318 and 9680794-2025-00325.

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 13 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21889595
• Report Number: 9680794-2025-00325
• Device Sequence Number: 3443157
• Product Code: DQY
• UDI-Device Identifier: 00801902102140
• UDI-Public: (01)00801902102140(11)230222(17)270930(10)14F23B0188(21)
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2025

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
• Device Catalogue Number: CS-14402
• Device Lot Number: 14F23B0188
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 04/23/2025
• Supplement Report FDA Received Date: 05/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2023
• 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