MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI-LUMEN/PSI KIT; INTRODUCER CATHETER

Catalog Number	CA-11142
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "test of the brown mac line for blood draw via the brown lumen: presence of a yellowish/beige clot in the lumen.The brown line was closed according to protocol with a pulsed flush of 20 ml of 0.9% nacl and a 3 ml heparin lock on (b)(6) at 6:00 am.The distal line remained open with a continuous infusion of 10 ml of 0.9% nacl until the thrombotic occlusion clot was observed in the brown lumen.Catheter removal revealed the presence of the clot in both the proximal and distal lumens.The patient was reported as fine post the procedure with no harm or consequences.".
Event or Problem Description
It was reported that: "test of the brown mac line for blood draw via the brown lumen: presence of a yellowish/beige clot in the lumen.The brown line was closed according to protocol with a pulsed flush of 20 ml of 0.9% nacl and a 3 ml heparin lock on (b)(6) at 6:00 am.The distal line remained open with a continuous infusion of 10 ml of 0.9% nacl until the thrombotic occlusion clot was observed in the brown lumen.Catheter removal revealed the presence of the clot in both the proximal and distal lumens.The patient was reported as fine post the procedure with no harm or consequences.".
Additional Manufacturer Narrative
(b)(4).The report of a catheter obstructed by a clot was not confirmed through analysis of the returned sample.The customer returned one mac catheter.Two valve activated hubs were attached to both the distal and proximal extension lines.Signs-of-use were observed inside the mac catheter.Visual, dimensional, and functional analysis of the returned sample did not reveal any evidence of a clot or of any manufacturing issues with the returned catheter.The product development team noted that patient condition, catheter care practices, medication use, and dwell time may all contribute to clot formation in the mac.Clinical reviewers stated that the mac is not intended for central venous pressure monitoring and using it for this purpose may led to occlusion if higher-volume routine flushing is not performed.They also reported that the mac and psi catheter tips do not terminate centrally, which increases the risk of t hrombosis and occlusion.Additionally, left-sided placements and right-sided mid-neck insertions tend to result in higher catheter tip positions associated with a greater risk of occlusion.A device history record review did not reveal any relevant findings.Therefore, no problem was found with the returned device; however, the root cause cannot be determined as the patient conditions, catheter maintenance, and indwell time can contribute to clots forming during use.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW MULTI-LUMEN/PSI KIT
• Common Device Name: INTRODUCER CATHETER
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 23530735
• Report Number: 9680794-2025-00927
• Device Sequence Number: 10187224
• Product Code: DYB
• UDI-Device Identifier: 10801902024418
• UDI-Public: (01)10801902024418(11)250805(17)290228(10)33F25D0298(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K002507
• 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): 10/20/2025

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 Catalogue Number: CA-11142
• Device Lot Number: 33F25D0298
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2025
• Supplement Date Received by Manufacturer: 11/20/2025
• Initial Report FDA Received Date: 11/12/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/25/2024
• 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.
• Patient Sex: Unknown