MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 16 CM; CATHETER PERCUTANEOUS

Model Number	IPN918521
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that "cvc placement guided by ultrasound.Vascular puncture without any complaints, guidewire is passed through the needle and gets stuck a bit inside the needle.Then it cannot be reversed but starts to wind up at the end that sticks out of the needle.Needle, with guidewire still in the needle, is removed from the patient and a new cvc set is used." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "unaffected by the incident".
Event or Problem Description
It was reported that "cvc placement guided by ultrasound.Vascular puncture without any complaints, guidewire is passed through the needle and gets stuck a bit inside the needle.Then it cannot be reversed but starts to wind up at the end that sticks out of the needle.Needle, with guidewire still in the needle is removed from the patient and a new cvc set is used." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "unaffected by the incident".
Additional Manufacturer Narrative
(b)(4).The customer-reported guidewire unraveling was confirmed through examination of the returned sample.Visual inspection revealed that the guidewire was unraveled in the distal j-bend region, with the spring coil appearing stretched.The spring coil was advanced into the needle, while the core wire was not observed within the needle.No obvious kinking was observed in the guidewire.The guide wire met all dimensional requirements during investigation testing.Functional inspection could not be performed because the unraveled portion of the guidewire, specifically the spring coil advanced into the needle in the absence of the core wire, was lodged within the cannula and could not be removed.No manufacturing-related defects or anomalies were identified during the investigation; a device history record review did not reveal any manufacturing-related issues.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, the unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2-LUMEN 7 FR X 16 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 24741679
• Report Number: 3006425876-2026-00359
• Device Sequence Number: 9230323
• Product Code: OWL
• UDI-Device Identifier: 10801902105216
• UDI-Public: (01)10801902105216(11)250512(17)290930(10)71F25D1209(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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2026

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 Model Number: IPN918521
• Device Catalogue Number: CV-12702
• Device Lot Number: 71F25D1209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2026
• Supplement Date Received by Manufacturer: 04/10/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2025
• 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