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

Catalog Number CU-25122-F

Device Problem Material Twisted/Bent (2981)

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

Event Date 01/29/2024

Event Type  malfunction  

Event Description

It was reported "the swg was found kinked during used on the patient".No medical intervention required.The patient condition is reported as "fine".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn# (b)(4).The customer provided one image showing a guide wire assembly.The guide wire was observed to be kinked.It was also noted that the straightener tubing and cap were removed from the assembly and not pictured.The customer returned one guide wire assembly for analysis.The straightener tubing and cap were not included.Signs of use in the form of biological material were observed on the guide wire surface.Visual analysis revealed three kinks towards the distal end.This kinking resulted in the distal j-bend to be misshapen.Microscopic examination confirmed the damage and revealed that the distal and proximal welds were full and spherical.The kinks on the guide wire measured 655mm, 676mm, and 680mm from the proximal weld.The guide wire total length measured 685mm , which is within the specification limits of 678mm-688mm per the guide wire product drawing.The guide wire outer diameter measured 0.850mm, which is within the specification limits of 0.835mm-0.877mm per the guide wire product drawing.The returned guide wire was inserted through a lab inventory arrow raulerson syringe (ars)/introducer needle subassembly.Little to no resistance was encountered as the guide wire passed completely through the assembly.Performed per ifu statement , "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".A manual tug test confirmed that the distal and proximal welds were secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs 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." the report of a kinked guide wire was confirmed through complaint investigation.Visual analysis revealed that the guide wire was kinked on the distal j-bend.Despite the damage, the sample met all relevant dimensional and functional requirements, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported "the swg was found kinked during used on the patient".No medical intervention required.The patient condition is reported as "fine.".

• Brand Name: ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 20 CM
• Type of Device: 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18737978
• MDR Text Key: 335749937
• Report Number: 3006425876-2024-00133
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K862056
• 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: 01/29/2024

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: CU-25122-F
• Device Lot Number: 71F23D0185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/20/2024
• Supplement Dates Manufacturer Received: 03/14/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2023
• 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: NONE REPORTED; NONE REPORTED