MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Catalog Number	CS-12854-E
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported during the cvc insertion procedure, the guidewire got stuck within the cvc and could not be removed.The cvc and guidewire were removed together and a new cvc was used to complete the procedure.
Event or Problem Description
It was reported during the cvc insertion procedure, the guidewire got stuck within the cvc and could not be removed.The cvc and guidewire were removed together and a new cvc was used to complete the procedure.
Additional Manufacturer Narrative
(b)(4).The customer provided one photo for analysis.The report of a kinked guide wire was able to be confirmed by the photo.The customer returned one guide wire and the product lidstock for evaluation.The catheter was not returned.Signs of use were observed on the guide wire.Visual inspection of the guide wire revealed several kinks throughout the guide wire body.The distal j-bend was misshapen but intact.Microscopic examination confirmed the damage.Both welds were present and appeared full and spherical.Visual inspection of the catheter could not be performed as it was not returned for analysis.The major kinks in the guide wire measured 55mm and 378mm from the distal weld.The guide wire length measured 602mm 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.Functional inspection of the returned guide wire was performed per the instructions for use (ifu) provided with the 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 threaded through a lab inventory 18 ga introducer needle and ars.Resistance was only observed at the kinked portions of the guide wire.A manual tug test confirmed the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The instructions for use (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 confirmed through complaint investigation of the returned sample.The catheter was not returned.Visual inspection revealed several 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, and without the complete sample returned for analysis, the probable root cause could not be determined.Teleflex will continue to monitor and trend for complaints of this nature.
Event or Problem Description
It was reported during the cvc insertion procedure, the guidewire got stuck within the cvc and could not be removed.The cvc and guidewire were removed together and a new cvc was used to complete the procedure.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi # udi related data quality updates only.

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• 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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17895006
• Report Number: 3006425876-2023-00994
• Device Sequence Number: 6979902
• Product Code: DQY
• UDI-Device Identifier: 00801902028983
• UDI-Public: (01)00801902028983(11)220829(17)260930(10)71F22H3671(21)
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (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): 09/12/2023

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 Expiration Date: 09/30/2026
• Device Catalogue Number: CS-12854-E
• Device Lot Number: 71F22H3671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: 10/31/2023; Not provided
• Initial Report FDA Received Date: 10/09/2023
• Supplement Report FDA Received Date: 11/01/2023; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• 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