MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 2-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CA-27702
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The customer returned one, opened cvc kit including one guide wire within its advancer for analysis.The arrow raulerson syringe (ars) was not returned.Signs of use were observed on the guide wire.Visual analysis revealed the distal end of the guide wire appeared kinked and there was an overall bend to the guide wire body.Microscopic examination confirmed the damage.Both welds were present and were observed to be full and spherical.Visual inspection of the ars could not be performed as the ars was not returned.The kinks in the guide wire measured 19 mm and 23 mm from the distal tip.The overall length of the guide wire measured 603 mm, which is within the specification limits of 596-604 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.790 mm , which is within the specification limits of 0.788-0.826 mm per guide wire product drawing.Dimensional inspection of the ars could not be performed as the ars was not returned.The guide wire was functionally tested per the product instructions-for-use (ifu).The ifu provided with this kit instructs the user, "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 little to no resistance.Functional inspection of the ars could not be performed as the ars was not returned.The report of guide wire and ars resistance was not confirmed through complaint investigation of the returned sample.The guide wire had two kinks towards the distal end of the body, and the ars was not returned.The returned guide wire met all relevant dimensional/functional requirements.A device history record review did not reveal any evidence of a manufacturing related issue.Based on these circumstances, unintentional user error likely contributed to this event, however, the probable cause of guide wire and ars resistance could not be determined based upon the information provided and without the ars being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported that: "(b)(6) 2024, the swg can't go through the ars due to the thin inside of ars.The issue was identified prior to the patient.They complaint the needle cannula is too thin for the ars.Involved 1 pc.".

• Brand Name: ARROW CVC KIT: 2-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: elaine cully ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 20118155
• Report Number: 9680794-2024-00910
• Device Sequence Number: 7446786
• Product Code: FOZ
• UDI-Device Identifier: 10801902099263
• UDI-Public: (01)10801902099263(11)240318(17)250815(10)33F24B0454(21)
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K900263
• 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
• Report Date (Section B): 08/28/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/15/2025
• Device Catalogue Number: CA-27702
• Device Lot Number: 33F24B0454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Initial Report FDA Received Date: 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• 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.
• Patient Sex: Unknown