MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CV-47702-E
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported "during the passage of the catheter, the tip expanded, making it impossible for it to progress." the user changed to a new set.There was no patient harm or injury.No medical intervention required.The patient's current condition is reported as "fine".Associated mdr number includes: 3006425876-2025-00379.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one two-lumen catheter and a guidewire for analysis.Signs of use in the form of biomaterial were observed on the returned components.Visual examination revealed the guidewire was unraveled from the proximal end.There were also multiple kinks throughout the guidewire body.The distal j-bend intact but slightly misshapen.The spring coil was still attached at the distal end.Microscopic examination of the guidewire confirmed the core wire was broken adjacent to the proximal weld.The exposed proximal core wire tip was tapered at the point of separation.Both welds were present and appeared full and spherical.The distal weld was still intact.The kinks in the guidewire body measured at 289mm, 397mm, 454mm, and 556mm from the proximal tip of the core wire.The overall length of the broken core wire measured 598mm, which is within the specification limits of 596mm - 604mm per the guidewire product drawing; therefore, no pieces of the core wire were missing.The outer diameter of the guidewire measured 0.80mm, which is within the specification limits of 0.788mm - 0.826mm per the guidewire product drawing.Functional testing was not able to be performed due to the nature of the damage.A manual tug test confirmed that the distal weld was intact.A device history record review was performed, and no relevant manufacturing issues were identified.The instructions for use (ifu) provided with this product 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.Warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the report that the guidewire unraveled during use was confirmed through examination of the returned sample.The core wire was broken adjacent to the proximal weld.The guidewire met all relevant dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.Arrow guidewires 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.Guidewire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error likely 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 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: keona jones ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21993729
• Report Number: 3006425876-2025-00457
• Device Sequence Number: 4478645
• Product Code: FOZ
• UDI-Device Identifier: 10801902102536
• UDI-Public: (01)10801902102536(11)240515(17)260306(10)71F24E0017(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K993691
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/21/2025

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
• Device Expiration Date: 03/06/2026
• Device Catalogue Number: CV-47702-E
• Device Lot Number: 71F24E0017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/15/2024
• 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