MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 12 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number	CS-22123-F
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#(b)(4).
Event or Problem Description
It was reported the spring wire guide (swg) unraveled when removing the guidewire from the catheter in the vessel.The insertion site was the subclavian vein and the vessel was tortuous.It was reported the guidewire was "removed entirety and not with any intervention performed, just slowly pulled out".The device was replaced and a second attempt was successful at the same insertion site.No patient injury was reported.It was reported "the patient was expired unfortunately, not because of the unraveled swg".Additional information was requested but was not available at the time of this report.
Additional Manufacturer Narrative
(b)(4).Additional information was received indicating the hospital could not provide patient information; however, the sales rep stated that the patient was geriatric with comorbidities and bed bound.The customer provided one photo for analysis.The supplied photo revealed that the guide wire had unraveled during use.The customer also returned one spring wire guide (swg) for evaluation.No other components were returned.Visual inspection of the swg revealed a kink in the body.The swg was unraveled as the core wire was broken adjacent to the distal weld.The j-bend shape was still present in the core wire.Microscopic examination confirmed both welds were full and spherical.The kink in the guide wire was measured at 290mm from the proximal weld.Total length of the core wire was measured at 601mm which is within the specification of 596mm - 604mm per product drawing; therefore no pieces of the core wire appear to be missing.The outer diameter of the undamaged guidewire measured at 0.840mm which is within the specification of 0.838mm - 0.877mm per product drawing.The undamaged portion of the guide wire was advanced through a lab inventory ars and a lab inventory 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 instructions for use 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.Do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." 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.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.
Event or Problem Description
It was reported the spring wire guide (swg) unraveled when removing the guidewire from the catheter in the vessel.The insertion site was the subclavian vein and the vessel was tortuous.It was reported the guidewire was "removed entirety and not with any intervention performed, just slowly pulled out".The device was replaced and a second attempt was successful at the same insertion site.No patient injury was reported.It was reported "the patient was expired unfortunately, not because of the unraveled swg".

• Brand Name: ARROW CVC SET: 3-LUMEN 12 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: 17538011
• Report Number: 3006425876-2023-00752
• Device Sequence Number: 17728459
• Product Code: FOZ
• UDI-Device Identifier: 00801902102188
• UDI-Public: 00801902102188
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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: 10/06/2024
• Device Catalogue Number: CS-22123-F
• Device Lot Number: 71F22M0065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 08/13/2023
• Supplement Report FDA Received Date: 09/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• 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
• Patient Sex: Unknown