MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2; CATHETER INTRAVASCULAR THERAP

Catalog Number CDC-45703-P1A

Device Problems Unraveled Material (1664); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 12/01/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The complaint is reported as: "the guidewire became frayed and unraveled while trying to withdraw the wire once the central line was placed.The line could not be flushed (brown port) which concerns the nurse for retained parts of the guidewire itself." no additional information was available at the time of this report.

Manufacturer Narrative

(b)(4) the customer returned one guide wire and product insert for evaluation.The catheter was not returned.The guide wire was unraveled and separated, and showed evidence of use.Visual examination revealed the guide wire is unraveled from both welds and has multiple kinks in the guide wire body.Both the distal and proximal ends of the core wire are broken and protruding out of the coil wire.The distal weld is attached to the coil wire, while the proximal weld separated from both the core and coil wires.The distal j-bend is misshapen but intact.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the distal weld and that the weld was present at the end of the coil wire.The proximal weld was not present at the end of the coil wire.The exposed core wire tips are rounded, pinched and discolored at the point of separation.The major kinks in the guide wire body were measured at 218 mm and 291 mm from the distal tip.The broken core wire measured 597 mm in length which is within the specification of 596 - 604 mm per guide wire product drawing; therefore no pieces of the core wire appear to be missing.The outside diameter of the guide wire measured 0.80 mm which is within the outer diameter specification of 0.788 - 0.826 mm per guide wire product drawing.A device history record review was performed on the guide wire and catheter and no relevant manufacturing issues were identified.The instructions-for-use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring wire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3 cm and attempt to remove the spring-wire guide.If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.The report that the guide wire was separated was confirmed through examination of the returned sample.The guide wire core wire was broken adjacent to both welds, and the proximal weld separated from both the core and coil wires.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, however, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the catheter being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint is reported as: "the guidewire became frayed and unraveled while trying to withdraw the wire once the central line was placed.The line could not be flushed (brown port) which concerns the nurse for retained parts of the guidewire itself.".

• Brand Name: ARROW MULTI-LUMEN PI CVC KIT: 3-L 7 FR X 8" (2
• Type of Device: CATHETER INTRAVASCULAR THERAP
• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 13655957
• MDR Text Key: 286647771
• Report Number: 9680794-2022-00138
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2022
• Device Catalogue Number: CDC-45703-P1A
• Device Lot Number: 13F20M0001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1