MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 4 FR X 5 CM; CATHETER PERCUTANEOUS

Model Number	IPN055153
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562); Unraveled Material (1664)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	12/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during central venous catheter (cvc) insertion via the internal jugular vein; the spring wire guide (swg) became stuck within the patient and unraveled upon removal.Additional information indicated that computed tomography (ct) performed immediately following the event confirmed that a fragment of the swg remained in the soft tissues outside of the vascular system.No medical intervention was undertaken to remove the retained fragment.The patient subsequently died on (b)(6) 2026 due to underlying disease.The death was not attributed to the reported device issue.
Additional Manufacturer Narrative
(b)(4).

• Brand Name: ARROW CVC SET: 2-LUMEN 4 FR X 5 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 25334772
• Report Number: 3006425876-2026-00569
• Device Sequence Number: 13180679
• Product Code: OWL
• UDI-Device Identifier: 10801902184419
• UDI-Public: (01)10801902184419(11)210524(17)260228(10)71F21E1903(21)
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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 Expiration Date: 02/28/2026
• Device Model Number: IPN055153
• Device Catalogue Number: CS-12402
• Device Lot Number: 71F21E1903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 05/29/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2021
• 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