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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	03/27/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "at the end of central venous catheter installation by general surgery surgeons, signs of thrombosis are observed, reported by a neurosurgery resident.During the same procedure, cvc placement was performed, initially in the femoral artery and attempted bilaterally without obtaining return or guide passage; and finally, it was successful in the left subclavian artery.On admission to the floor, the patient was described as having increased volume with erythematous coloration of the right lower extremity, pulses of adequate intensity, capillary refill of 2 seconds, negative godette's sign, no pain on thigh or leg pressure, negative homans' and olow's signs, the patient was diagnosed with femoral deep vein thrombosis, so a doppler ultrasound (us) of said extremity was requested, where he verbally confirmed the diagnosis due to the recent diagnosis of thrombosis, and was evaluated by hematology, who requested bh laboratories, in addition to adding treatment with enoxaparin (1 mg/kg/do) c/12h," the patient's current condition is described as "progressing favorably".
Event or Problem Description
It was reported "at the end of central venous catheter installation by general surgery surgeons, signs of thrombosis are observed, reported by a neurosurgery resident.During the same procedure, cvc placement was performed, initially in the femoral artery and attempted bilaterally without obtaining return or guide passage; and finally, it was successful in the left subclavian artery.On admission to the floor, the patient was described as having increased volume with erythematous coloration of the right lower extremity, pulses of adequate intensity, capillary refill of 2 seconds, negative godette's sign, no pain on thigh or leg pressure, negative homans' and olow's signs, the patient was diagnosed with femoral deep vein thrombosis, so a doppler ultrasound (us) of said extremity was requested, where he verbally confirmed the diagnosis due to the recent diagnosis of thrombosis, and was evaluated by hematology, who requested bh laboratories, in addition to adding treatment with enoxaparin (1 mg/kg/do) c/12h," the patient's current condition is described as "progressing favorably".
Additional Manufacturer Narrative
(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of catheter related thrombosis 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 a thrombosis related event from the photo.However, based on the information provided in the report, the complaint can be confirmed as the patient underwent diagnostic ultrasound that confirmed deep vein thrombosis.Full complaint verification testing 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, "clinicians must be aware of complications/undesirable side-effects associated with central venous catheters including, but not limited to: thrombosis.Do not place/advance catheter into or allow it to remain in the right atrium or right ventricle.The catheter tip should be advanced into the lower 1/3 of the superior vena cava.For femoral vein approach, catheter should be advanced into vessel so catheter tip lies parallel to vessel wall and does not enter right atrium.Catheter tip location should be confirmed according to institutional policy and procedure." 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.

• 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: 21864171
• Report Number: 9680794-2025-00318
• Device Sequence Number: 7888537
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• 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: 03/28/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 04/18/2025
• 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