MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2L 5 FR X 13 CM; CATHETER PERCUTANEOUS

Catalog Number	CS-14502
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: the swg was found to be kinked.The issue was identified prior to use on patient.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: the swg was found to be kinked.The issue was identified prior to use on patient.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).The customer returned one guide wire assembly and a lidstock for analysis.The wire snubber component was missing from the tubing assembly.No signs of use were present on the swg.Visual inspection of the swg revealed one kink towards the proximal end.During normal assembly, the kink would be located outside the tubing where the swg is inserted through the wire snubber.The wire snubber was not present on the returned sample and it cannot be verified if the snubber was present prior to the customer handling.Similarly, it is unknown if the guide wire became kinked as a result of the snubber being removed from the assembly.A lab inventory snubber was assembled to the tubing.The kink was located at the location where the guide wire meets the snubber.Microscopic examination confirmed both welds were present and spherical.While removing/reinserting the guide wire from the tubing, a small kink formed on the distal j-bend.This small kink was not present upon sample receipt from the customer.The kink on the guide wire measured 11mm from the proximal weld.The total length of the swg measured 17 15/16", which is within the specification limits of 17 11/16"-18 1/16" per the guide wire product drawing.The outer diameter of the swg measured 0.020", which is within specifications of 0.020"-0.0210" per the guide wire product drawing.The returned swg was functionally tested per the instructions for use (ifu).The ifu provided with this kit states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle".The undamaged portions of the wire passed through a lab inventory 20 ga introducer needle with minimal resistance.A manual tug test confirmed the distal and proximal welds were secure.Manufacturing was contacted as part of this complaint investigation.They confirmed that the guide wire assemblies are 100% inspected for kinking.This includes ensuring the snubber is correctly attached to the tubing.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "do not use if package has been previously opened or damaged".The report of a guide wire kinking was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the guide wire was kinked in an exposed area of the assembly.It was also noted that the snubber component was missing from the proximal end of the tubing.Despite the damage, all relevant dimensional and functional requirements were met, and a device history record review did not reveal any relevant findings.Based on the customer report and the sample received, the root cause cannot be determined as it is unknown if the snubber was present before the customer handled.Likewise, it is unknown if the removal of the snubber resulted in the guide wire to become kinked.Based on these circumstances, the probable root cause is undetermined.Teleflex will continue to monitor and trend for reports of this nature.Section d.1.-brand name corrected to arrow cvc set: 2l 5 fr x 13 cm.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi # **udi related data quality updates only** corrected data:.
Event or Problem Description
It was reported that: the swg was found to be kinked.The issue was identified prior to use on patient.There was no patient involvement.

• Brand Name: ARROW CVC SET: 2L 5 FR X 13 CM
• Common Device Name: 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17850812
• Report Number: 3006425876-2023-00948
• Device Sequence Number: 16982357
• Product Code: DQY
• UDI-Device Identifier: 30801921122939
• UDI-Public: 30801921122939
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/06/2023

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
• Operator of Device: Health Professional
• Device Catalogue Number: CS-14502
• Device Lot Number: 71F22J3152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 10/25/2023; Not provided
• Initial Report FDA Received Date: 10/02/2023
• Supplement Report FDA Received Date: 10/25/2023; 07/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2022
• 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; NOT REPORTED
• Patient Sex: Unknown