MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2L 5 FR X 13 CM; CATEHTER HEMODIALYSIS NON IMPL

Catalog Number CS-14502

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 11/20/2023

Event Type  malfunction  

Event Description

It was reported that: the swg was found to be kinked during use on patient.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: the swg was found to be kinked during use on patient.

Manufacturer Narrative

Qn# (b)(4).The customer provided one photo for analysis.The customer also returned an opened cvc kit including one swg in its advancer for evaluation.The guide wire was returned within the advancer tube and showed evidence of use.The guide wire was observed to have multiple kinks towards both the distal and proximal ends of the body.The distal j-bend was misshapen but intact.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.The major kinks in the guide wire were located 11mm, 31mm, 42mm, 429mm, 445mm, and 449mm from the proximal tip.The overall length of the guide wire measured 456 mm which is within the specification of 449.2-458.8 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.512 mm which is within the specifications of 0.508-0.533 mm per guide wire product drawing.The guide wire was advanced through a lab inventory ars and 20ga introducer needle to functionally test the guide wire.The guide wire passed through both components with little to no resistance.Performed per the instructions for use (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 both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution , "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage." the report that the guide wire kinked during use was confirmed through examination of the returned sample.The guide wire had multiple kinks towards both the distal and proximal tips.The returned guide wire met all relevant dimensional/functional requirements, and a device history record review did not identify any manufacturing related issues.Based on the condition of the guide wire and the report that the damage was observed during use, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 2L 5 FR X 13 CM
• Type of Device: CATEHTER HEMODIALYSIS NON IMPL
• 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: 18333691
• MDR Text Key: 330554012
• Report Number: 3006425876-2023-01245
• Device Sequence Number: 1
• Product Code: MPB
• UDI-Device Identifier: 30801921122939
• UDI-Public: 30801921122939
• 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: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2023

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-14502
• Device Lot Number: 71F22J3152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/15/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2022
• 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.