MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-15123-F
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported the physician was inserting the line "on a critically ill patient, insertion went fine but upon removing the wire uncoiled.It appears to be completely removed." the patient's condition was reported as critical.Additional information was requested but not available at the time of this report.
Additional Manufacturer Narrative
Qn#(b)(4).The actual device was not returned; however, the customer provided one photo for analysis.The complaint of an unraveled guide wire was able to be confirmed by the photo.A complete visual inspection could not be performed as no sample was returned for analysis.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 an unraveled guide wire was confirmed by visual inspection of the customer supplied photo.However, full complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed, and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported the physician was inserting the line "on a critically ill patient, insertion went fine but upon removing the wire uncoiled.It appears to be completely removed." the patient's condition was reported as critical.Additional information was requested but not available at the time of this report.
Additional Manufacturer Narrative
Qn#(b)(4).The customer provided one image showing a severely unraveled guide wire.The customer also returned one defective guide wire and a lidstock for analysis.Signs of use in the form of biological material were observed on the guide wire.Visual analysis revealed the guide wire is unraveled from the distal weld and is kinked/distorted in several locations along the body.The core wire distal j-bend was deformed.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the distal weld.Both welds were present and appeared full and spherical.The guide wire length from the proximal weld to the broken core wire measured 680mm , which is within the specification limits of 678mm-688mm per guide wire product drawing.The outside diameter of the guide wire measured 0.84mm , which is within the outer diameter specification of 0.838mm-0.877mm per guide wire product drawing.Functional analysis of the returned guide wire could not be accurately performed due to the severity of the damage.A manual tug test confirmed that the proximal weld was secure and intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs 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 ifu also states, "do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire".The report that the guide wire unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the distal weld.The guide wire met all dimensional requirements during investigation testing.No manufacturing defects were found during this investigation.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 caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported the physician was inserting the line "on a critically ill patient, insertion went fine but upon removing the wire uncoiled.It appears to be completely removed." the patient's condition was reported as critical.Additional information was requested but not available at the time of this report.

• Brand Name: ARROW CVC SET: 3-LUMEN 12 FR X 20 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: 17666074
• Report Number: 3006425876-2023-00847
• Device Sequence Number: 17694065
• Product Code: FOZ
• UDI-Device Identifier: 00801902102164
• UDI-Public: 00801902102164
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K970864
• 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): 08/08/2023

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 Catalogue Number: CS-15123-F
• Device Lot Number: 71F22K1941
• 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: 08/08/2023
• Supplement Date Received by Manufacturer: 09/26/2023; 01/04/2024
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 10/02/2023; 01/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/19/2022
• 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