MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER,INTRAVASCULAR,THERAP

Catalog Number	CV-25703-E
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that "a single puncture is performed in the left infraclavicular region until venous return is obtained.The metal guide is advanced easily, followed by the dilator and then the catheter.When attempting to retrieve the guide, deformation of the guide is observed, so it is decided to completely remove the catheter.A second catheter is requested and the procedure is repeated: single puncture in the left infraclavicular region until venous return is obtained, metal guide advanced easily, advancement of the dilator and catheter.Then, the metal guide is retrieved, the catheter is fixed at 18 cm, and the lines are tested and flushed." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
(b)(4).The actual sample was not returned; however, the customer provided two photos for analysis.The complaint of an unraveled guide wire was confirmed.The catheter involved with this event was not pictured.The image shows a guidewire in a clinical setting with evidence of unraveling; however, a full visual analysis to determine the cause of the damage could not be performed without the catheter and the guide wire returned for analysis.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "do not use excessive force when introducing guidewire or tissue dilator as this can lead to vessel perforation, bleeding, or component damage".The ifu also states, "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".Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.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.Regardless of these circumstances, the root cause cannot be determined as no sample was returned.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "a single puncture is performed in the left infraclavicular region until venous return is obtained.The metal guide is advanced easily, followed by the dilator and then the catheter.When attempting to retrieve the guide, deformation of the guide is observed, so it is decided to completely remove the catheter.A second catheter is requested and the procedure is repeated: single puncture in the left infraclavicular region until venous return is obtained, metal guide advanced easily, advancement of the dilator and catheter.Then, the metal guide is retrieved, the catheter is fixed at 18 cm, and the lines are tested and flushed." there was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 20CM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 24290750
• Report Number: 3006425876-2026-00111
• Device Sequence Number: 10324445
• Product Code: FOZ
• UDI-Device Identifier: 10801902029390
• UDI-Public: (01)10801902029390(11)250429(17)270327(10)71F25D0807(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K900263
• 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): 01/13/2026

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
• Device Catalogue Number: CV-25703-E
• Device Lot Number: 71F25D0807
• 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: 01/13/2026
• Supplement Date Received by Manufacturer: 03/02/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2025
• 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