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

Catalog Number CS-25122-F

Device Problem Unraveled Material (1664)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: the swg unravelled during use on patient when removing the swg from the catheter.A new set was used and there was no reported patient harm or consequence.

Event Description

It was reported that: the swg unravelled during use on patient when removing the swg from the catheter.A new set was used and there was no reported patient harm or consequence.

Manufacturer Narrative

Qn # (b)(4).The report that the guide wire unravelled was confirmed through examination of the returned sample.The customer provided three photos for analysis and returned an opened hemodialysis kit including a swg and its advancer.The swg was not within its advancer.The components showed signs of use in the form of dried blood.Visual examination revealed the guide wire was unravelled from the proximal weld and was kinked in several locations along the body.The distal j-bend was not misshapen and was intact.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the proximal weld.The core wire tip was tapered and discoloured at the point of separation.Both welds were present and appeared full and spherical.The major kinks in the guide wire body were measured at 245mm, 286mm, and 334mm via calibrated ruler from the distal tip.The broken core wire measured 684 mm in length via calibrated ruler, which was within the specification of 678-688 mm per guide wire product drawing; therefore, no pieces of the core wire appear to be missing.The outside diameter (od) of the guide wire measured 0.844 mm via calibrated micrometer which was within the od specification of 0.838-0.877 mm per guide wire product drawing.Functional testing was performed per the instructions-for-use (ifu), "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the distal end of the guide wire was advanced through a lab inventory ars/18ga introducer needle assembly, and the undamaged portions of the guide wire pass through both components with little to no resistance.A manual tug test confirmed that the distal weld was intact.The instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage." a device history record review did not reveal any evidence of a manufacturing related issue.Arrow guide wires of this size were designed and manufactured to withstand a tensile force of 2.75 pounds force.The selected insertion site and patient anatomy might present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage might occur if a force greater than the design specification was applied during removal.Based on these circumstances, unintentional use error likely contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Type of Device: CATHETER HEMODIALYTSIS NON IMP
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18149064
• MDR Text Key: 328755132
• Report Number: 3006425876-2023-01069
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801902100207
• UDI-Public: 00801902100207
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

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: CS-25122-F
• Device Lot Number: 71F23C0406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 12/06/2023
• Supplement Dates FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/10/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED; NOT REPORTED