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 Material Twisted/Bent (2981)

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

Event Date 01/11/2024

Event Type  malfunction  

Event Description

It was reported "the swg was found kinked during use on the patient".No medical intervention required.Patient's current condition is "fine".

Manufacturer Narrative

(b)(4).

Event Description

It was reported "the swg was found kinked during use on the patient".No medical intervention required.Patient's current condition is "fine".

Manufacturer Narrative

Qn#(b)(4) the customer provided one image showing a guide wire assembly.The report of a kinked guide wire was confirmed by the photo.The customer returned a single guide wire assembly for evaluation.Signs of use in the form of biological material were observed on the guide wire.The guide wire was observed to have one kink towards the distal end of the body.The distal j-bend was slightly misshapen but intact.Microscopic examination confirmed the kinking and revealed that both welds were present and were observed to be full and spherical.After performing dimensional analysis, it was discovered that the returned guide wire does not match the length requirements for the guide wire packaged within the reported finished good.Therefore, it cannot be determined if the incorrect sample was returned or if the incorrect finished good material#/lot# was reported.The kink on the guide wire measured 575mm from the proximal weld.The overall length of the guide wire measured 603mm, which is not within the specification of 678mm-688mm per guide wire product drawing.The guide wire outer diameter measured 0.840mm, which is within the specification limits of 0.838mm-0.877mm per the guide wire product drawing.The discrepancy with the guide wire length indicates that the returned sample is not the same guide wire packaged within the reported finished good.The guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guide wire.Major resistance was observed at the kinking; however, the undamaged portion of the guide wire was able to pass as expected.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, "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 the guide wire was kinked towards the distal end; however, further dimensional analysis revealed that the guide wire length is not within the specification limits.Despite this, the guide wire met all relevant functional requirements, and a device history record review (on the reported finished good) was performed with no relevant findings.The kinking appears consistent with damage caused from undue force applied during insertion; however, due to the discrepancy with the guide wire dimensions, the root cause cannot be determined as it is unknown if the incorrect sample was returned or if the incorrect finished good was reported.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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18601485
• MDR Text Key: 334002157
• Report Number: 3006425876-2024-00084
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 00801902100207
• UDI-Public: 00801902100207
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K993933
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

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: CS-25122-F
• Device Lot Number: 71F23D0177
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 02/13/2024
• Supplement Dates FDA Received: 02/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2023
• 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