MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number	CU-25122-F
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	02/06/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "on (b)(6) 2024, the hematologist informed the patient that after successful catheterization and hemofiltration treatment, a follow-up ultrasound was planned before extubation.The ultrasound showed hypoechoic attachment (thrombosis) around the right common femoral vein after catheterization.Following anticoagulation treatment for two weeks, the patient is currently under observation and treatment.
Event or Problem Description
It was reported that: "on (b)(6) 2024, the hematologist informed the patient that after successful catheterization and hemofiltration treatment, a follow-up ultrasound was planned before extubation.The ultrasound showed hypoechoic attachment (thrombosis) around the right common femoral vein after catheterization.Following anticoagulation treatment for two weeks, the patient is currently under observation and treatment.
Additional Manufacturer Narrative
(b)(4).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 to suggest a manufacturing related issue.The instructions for use (ifu) provided with this kit warns the user, "contraindications: the arrow large-bore two-lumen catheter is not designed for long-term (greater than or equal to 30 days) hemodialysis or for use in patients with thrombosed vessels." 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 HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18928523
• Report Number: 3006425876-2024-00257
• Device Sequence Number: 4540529
• Product Code: DQY
• UDI-Device Identifier: 00801902100276
• UDI-Public: 00801902100276
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 02/22/2024

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
• Device Expiration Date: 04/21/2024
• Device Catalogue Number: CU-25122-F
• Device Lot Number: 71F22J3396
• 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: 02/22/2024
• Supplement Date Received by Manufacturer: 03/27/2024
• Initial Report FDA Received Date: 03/19/2024
• Supplement Report FDA Received Date: 03/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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 Age: 59 YR
• Patient Sex: Female