MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN919426
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The complaint is reported as: "during procedure according to ifu, md found guide wire has no proper j-tip.So md opened up a new kit to finish the procedure." no patient injury/harm reported.The condition of the patient was reported as "fine".
Additional Manufacturer Narrative
Qn# (b)(4).The device was received for evaluation.Upon initial investigation it was observed that the spring wire guide was unraveled.Full investigation results will be provided upon completion of the investigation.
Event or Problem Description
The complaint is reported as: "during procedure according to ifu, md found guide wire has no proper j-tip.So md opened up a new kit to finish the procedure." no patient injury/harm reported.The condition of the patient was reported as "fine".
Additional Manufacturer Narrative
(b)(4), the customer returned one spring wire guide (swg) and a lidstock for evaluation.Visual inspection of the swg revealed multiple kinks in the body.The coil wire was separated from the distal weld and the swg was unraveled from the distal weld.The j-bend was still present in the core wire.Microscopic examination confirmed both welds were present and spherical.The main kinks in the guide wire measured 77 mm and 116 mm from the proximal weld.The total length of the core wire measured 455 mm which is within the specification of 450-458 mm per guide wire product drawing.The outer diameter of the undamaged portions measured 0.793 mm which is within the specification of 0.788-0.826 mm per guide wire product drawing.The undamaged portions of the guide wire were advanced through a lab inventory ars and a lab inventory 18ga introducer needle 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 guide wire passed through both components with minimal resistance.A manual tug test confirmed the proximal weld was intact.A device history record review was performed, and no relevant findings were identified.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 report that the guide wire was unraveled was confirmed through examination of the returned sample.The guide wire core wire was broken adjacent to the distal weld.Dimensional inspection and a device history record review did not reveal any evidence of a manufacturing related issue.Arrow guide wires of this size are designed and manufactured to withstand a tensile force of 2.75 pounds force.This internal specification is higher than the bs en iso 11070:2014 standard of 2.2 pounds force for this size wire.The selected insertion site and patient anatomy may present a tortuous path that could contribute to the possibility of guide wire kinking.Guide wire breakage may occur if a force greater than the design specification is applied during removal.Based on these circumstances, unintentional use error likely contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 16 CM
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• 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: 15881801
• Report Number: 3006425876-2022-01097
• Device Sequence Number: 2492994
• Product Code: FOZ
• UDI-Device Identifier: 10801902187151
• UDI-Public: 10801902187151
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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,Distributor
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2022

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: 02/29/2024
• Device Model Number: IPN919426
• Device Catalogue Number: CS-22703-E
• Device Lot Number: 71F22C1101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2022
• Supplement Date Received by Manufacturer: 12/15/2022
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 12/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2022
• 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
• Patient Sex: Unknown