MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 5.5FR X 8CM; CATHETER, PERCUTANEOUS

Catalog Number SA-15553

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problems Injury (2348); No Known Impact Or Consequence To Patient (2692)

Event Date 10/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The customer reports that post repair of the internal jugular vein the patient was fine.

Event Description

It was reported that the doctor inserted the central line guide wire into the right internal jugular.When the doctor tried to advance the catheter over the guide wire resistance was met.The doctor then removed the catheter and guide wire only to find that the guide wire had knotted.The patient then needed a surgeon to have the internal jugular repaired as the knot damaged the vessel upon removal.A new catheter was placed.The patient condition is reported as fine.

Manufacturer Narrative

Qn#(b)(4).The customer provided one photo for this investigation.The photo was of the spring wire guide and a knot is observed near the distal end.No other damage to the guide wire is observed.No other components from the kit are in the photo.Visual inspection of the physical sample could not be completed as the sample has not been returned.The product technology group engineer was contacted to better understand how knotting could occur with the spring wire guide.The response was that knotting can occur during manipulation of the swg in difficult vasculature.In general, the knotting is a result of the patient anatomy and the clinical technique that was used.A dhr review was completed with no relevant findings.The ifu provided within this kit warns the user "pulling back on the spring-wire guide may result in undue force being applied resulting in spring wire guide breakage.If resistance is encountered, withdraw catheter relative to spring-wire guide about 2-3 cm and attempt to remove spring-wire guide.If resistance is again encountered remove spring-wire guide and catheter simultaneously.Also, although the incidence of spring-wire guide failure is extremely low, practitioner should be aware of the potential for breakage if undue force is applied to the wire." the report that the guide wire knotted was confirmed through examination of the customer supplied photo.The image showed the guide wire knotted towards the distal end of the wire; however, the actual complaint sample was not returned for evaluation.The device history records for the guide wire and catheter were reviewed with no evidence to suggest a manufacturing related cause.The probable cause of the guide wire knotting could not be determined based upon the information provided and without the actual complaint sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that the doctor inserted the central line guide wire into the right internal jugular.When the doctor tried to advance the catheter over the guide wire resistance was met.The doctor then removed the catheter and guide wire only to find that the guide wire had knotted.The patient then needed a surgeon to have the internal jugular repaired as the knot damaged the vessel upon removal.A new catheter was placed.The patient condition is reported as fine.

Manufacturer Narrative

(b)(4).The customer returned one guide wire for evaluation.The wire contained obvious signs of use in the form of biological material.Visual examination confirmed a knot in the guidewire towards the distal end.Microscopic examination revealed the proximal weld was separated and not returned.The distal weld appeared fully spherical and intact.The total length of the guide wire could not be measured due to the knot near the distal end.The outer diameter of the guide wire measured to be 0.44 mm which is within specifications of 0.43-0.46 mm per product drawing.The guide wire could not be functionally tested with a lab inventory needle or catheter due to the knotted guide wire.A manual tug test confirmed the distal j-tip was fully intact.R & d and clinical were contacted as part of this complaint investigation.It was determined that the guide wire can become looped around the catheter as part of the insertion process.This is likely due to difficulty threading the catheter over the wire, therefore the catheter is advanced and retracted multiple times which can cause looping and knotting of the wire.Additionally, the guide wire would be unable to be threaded through the insertion needle and/or catheter while containing a knot which indicates that the guide wire became knotted in use, after a successful insertion.A device history record review was performed with no relevant findings.The instructions-for-use (ifu) provided with this kit instructs the user, "the arrow catheter included in this product has been designed to freely pass over the spring-wire guide.If resistance is encountered when attempting to remove spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel.In this circumstance, pulling back on the spring-wire guide may result in undue force being applied resulting in spring wire guide breakage.If resistance is encountered, withdraw catheter relative to spring-wire guide about 2-3 cm and attempt to remove spring-wire guide.If resistance is again encountered remove spring-wire guide and catheter simultaneously." the customer report of a knotted guide wire was confirmed by complaint investigation of the returned sample.The guide wire contained a knot near the distal end and the proximal weld was separated and not returned.Likewise, the guide wire is unable to be threaded through a needle while knotted, indicating that this damage occurred during use.A device history record review was performed with no relevant findings.Based on the sample received and engineering/clinical feedback, unintentional use error caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported that the doctor inserted the central line guide wire into the right internal jugular.When the doctor tried to advance the catheter over the guide wire resistance was met.The doctor then removed the catheter and guide wire only to find that the guide wire had knotted.The patient then needed a surgeon to have the internal jugular repaired as the knot damaged the vessel upon removal.A new catheter was placed.The patient condition is reported as fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 5.5FR X 8CM
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 9197498
• MDR Text Key: 162638291
• Report Number: 3006425876-2019-00809
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: SA-15553
• Device Lot Number: 71F19D0528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Date Manufacturer Received: 03/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 9 MO
• Patient Weight: 5