MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW JACC IR: 2-L 5.5FR NON-TIP 80 HNIT WIRE; CATHETER INTRAVASCULAR THERAPE

Catalog Number	JRT-43552-HPHNM
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "catheter fragmented and fractured.Line stopped working during rrt.Nurse tried cathflow with no response.Nurse requested a chest x-ray.The x-ray showed the catheter was fractured inside the chest.When reviewing the xray report in ir, the radiologist did retrieve part of the fractured catheter from the soft tissue in the right neck without complications.The line was removed with no complications and no harm to the patient." the patient's current condition is reported as "fine".
Event or Problem Description
It was reported "catheter fragmented and fractured.Line stopped working during rrt.Nurse tried cathflow with no response.Nurse requested a chest x-ray.The x-ray showed the catheter was fractured inside the chest.When reviewing the xray report in ir, the radiologist did retrieve part of the fractured catheter from the soft tissue in the right neck without complications.The line was removed with no complications and no harm to the patient." the patient's current condition is reported as "fine".
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.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.Precaution: when tunneling, the catheter must not be forced.Precaution: ensure catheter is not twisted during tunneling since this may result in catheter damage.Note: additional blunt dissection may be required to facilitate insertion if resistance is encountered." 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 JACC IR: 2-L 5.5FR NON-TIP 80 HNIT WIRE
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 24639501
• Report Number: 9680794-2026-00200
• Device Sequence Number: 15926558
• Product Code: LJS
• UDI-Device Identifier: 20801902129318
• UDI-Public: (01)20801902129318(11)241206(17)261031(10)33F24L0169(21)
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K161765
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/26/2026

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: JRT-43552-HPHNM
• Device Lot Number: 33F24L0169
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 03/19/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2024
• 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