MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM; CATHETER SUBCLAVIAN

Catalog Number	CS-15122-F
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that "the swg was inserted smoothly.There was a little resistance when removed, but it was not difficult.The doctor did not expect the swg to unravel, so he quickly removed it, causing the unravelled swg to puncture the nurse.This incident has been reported internally, and a new set has been opened.The patient is fine and had no harm or injury".The associated emdr report numbers are 3006425876-2025-00082, and 3006425876-2025-00171.
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
Qn#(b)(4).The customer provided one photo for analysis.The customer photo revealed an unraveled guide wire with its j-bend core wire exposed but still properly shaped.The customer also returned one guide wire and the product lidstock for analysis.The guide wire showed evidence of use in the form of dried biological material.Visual examination revealed the guide wire was unraveled from the distal weld and was kinked towards the distal end of the body.The core wire distal j-bend was exposed but still maintained its shape.The spring coil was still attached at the proximal end.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the distal weld.The exposed distal core wire tip was tapered at the point of separation.Both welds were present and appeared full and spherical.The proximal weld was still intact.The kink in the guide wire body measured at 90mm from the distal tip.The overall length of the broken core wire measured 686mm, which is within the specification limits of 678mm-688mm per guide wire product drawing; therefore, no pieces of the core wire were missing.The outer diameter of the guide wire measured 0.830mm, which is within the specification limits of 0.838mm-0.877mm per guide wire product drawing.Functional testing was not able to be performed due to the nature of the damage.A manual tug test confirmed that the proximal 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 guide wire unraveled during use was confirmed through examination of the returned sample.The core wire was broken adjacent to the distal weld.The guide wire met all relevant dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.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, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that "the swg was inserted smoothly.There was a little resistance when removed, but it was not difficult.The doctor did not expect the swg to unravel, so he quickly removed it, causing the unravelled swg to puncture the nurse.This incident has been reported internally, and a new set has been opened.The patient is fine and had no harm or injury".The associated emdr report numbers are 3006425876-2025-00082, 3006425876-2025-00081 and 3006425876-2025-00171.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Common Device Name: CATHETER SUBCLAVIAN
• 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: 21332016
• Report Number: 3006425876-2025-00081
• Device Sequence Number: 12794302
• Product Code: LFJ
• UDI-Device Identifier: 00801902100146
• UDI-Public: (01)00801902100146(11)230622(17)280531(10)71F23F1168(21)
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K895417
• 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): 01/13/2025

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: CS-15122-F
• Device Lot Number: 71F23F1168
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/22/2023
• 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