MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 8.5FR X 20CM; CATHETER, INTRAVASCULAR, THERAPEUTIC

Model Number	IPN918647
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: during the insertion of a central catheter in a patient, the doctor encountered an issue.When the guide was inserted into the dilator, the guide deformed/bent.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: during the insertion of a central catheter in a patient, the doctor encountered an issue.When the guide was inserted into the dilator, the guide deformed/bent.
Additional Manufacturer Narrative
(b)(4).The customer returned two guide wires within their advancer tubes for evaluation.One guide wire (appears unused) is the guide wire involved with this complaint.Per the customer report, the second guide wire (appears used) is the third guide wire used during this procedure.The customer reported that this 3rd guide wire was used without issue.Therefore, it is being assumed that the customer returned this guide wire for reference only.Visual inspection revealed no kinks throughout the guide wire body.Microscopic examination confirmed both welds were present and appeared full and spherical.The guide wire total length measured 598mm which is within the specifications of 596-604mm per product drawing.The guide wire outer diameter measured 0.81mm which is within the specifications of 0.788-0.826mm per product drawing.The returned guide wire was functionally tested per the instructions for use (ifu) provided with this kit which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was advanced through a lab inventory ars and a lab inventory 18ga introducer needle to functionally test the guide wire.The guide wire passed through both components with minimal resistance.A manual tug test confirmed the distal and proximal welds were intact.A device history record review was performed with no relevant findings.The 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.If damage is suspected or withdrawal cannot be easily accomplished , radiographic visualization should be obtained and further consultation requested." the customer report of a kinked guide wire was not confirmed through complaint investigation of the returned sample.Visual inspection did not reveal any kinks in the guide wire.The returned guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings.Based on these circumstances, no problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: during the insertion of a central catheter in a patient, the doctor encountered an issue.When the guide was inserted into the dilator, the guide deformed/bent.

• Brand Name: ARROW CVC SET: 3-LUMEN 8.5FR X 20CM
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC
• 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: 18309121
• Report Number: 3006425876-2023-01225
• Device Sequence Number: 6784297
• Product Code: DQY
• UDI-Device Identifier: 10801902029017
• UDI-Public: (01)10801902029017(11)220825(17)260930(10)71F22H2442(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/15/2023

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 Expiration Date: 09/30/2026
• Device Model Number: IPN918647
• Device Catalogue Number: CS-15853
• Device Lot Number: 71F22H2442
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2023
• Supplement Date Received by Manufacturer: 01/04/2024; Not provided
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 01/05/2024; 08/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/25/2022
• 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