MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 1-LUMEN 5 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number AK-04301-J

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2023

Event Type  malfunction  

Event Description

It was reported that: the swg could not be inserted into the 18ga introducer needle because of resistance during surgery.The user removed the swg from the 18ga introducer needle.The swg was found unraveled.Therefore, a new kit was opened instead.Additional information: the internal jugular vein was used for access.Ultrasound was used to gain access.The swg was removed in its entirety.The second insertion was successful.There was no reported patient harm.

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: the swg could not be inserted into the 18ga introducer needle because of resistance during surgery.The user removed the swg from the 18ga introducer needle.The swg was found unraveled.Therefore, a new kit was opened instead.Additional information: the internal jugular vein was used for access.Ultrasound was used to gain access.The swg was removed in its entirety.The second insertion was successful.There was no reported patient harm.

Manufacturer Narrative

Qn#: (b)(4).The customer returned a guide wire assembly, introducer needle, and product lidstock for evaluation.Definite signs of use were observed on the returned components.Visual analysis revealed that the guide wire was unraveled from the distal weld.The guide wire was additionally kinked.The distal j-bend of the core wire was slightly misshapen.Microscopic examination confirmed that the core wire was broken adjacent to the distal weld.Both welds were present and appeared full and spherical.Visual and microscopic examination revealed no obvious defects or anomalies on the introducer needle.The kink in the guide wire measured 571mm from the proximal end.The overall length of the guide wire core wire measured 603mm which is within the specification limits of 596mm - 604mm per the guide wire product drawing; therefore, no pieces of the core wire appear to be missing.The outer diameter of the guide wire measured 0.803mm which is within the specification limits of 0.788mm - 0.826mm per the guide wire product drawing.The outer diameter of the needle cannula measured 0.04980" which is within the specification limits of 0.0495" - 0.0505" the cannula drawing.The inner diameter of the needle cannula measured 0.041" which is within the specification limits of 0.041" - 0.043" the cannula drawing.The undam aged portion of the guide wire was threaded through the returned introducer needle and was able to pass with little to no resistance.Performed per the instructions for use statement, "advance guidewire into arrow raulerson syringe approximately 10 cm until it pas ses through syringe valves or into introducer needle.".A manual tug test confirmed that the proximal weld was secure and intact.A device history record review was performed, and there were no relevant findings.The ifu provided with this kit informs the user, "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire.".The report that the guide wire unraveled due to needle resistance was confirmed through examination of the returned sample.The core wire was broken adjacent to the distal weld.The guide wire and needle met all functional and dimensional requirements.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.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 caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC KIT: 1-LUMEN 5 FR X 20 CM
• Type of Device: CATHETER PERCUTANEOUS
• 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: 17903674
• MDR Text Key: 325263203
• Report Number: 3006425876-2023-00967
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 00801902101914
• UDI-Public: 00801902101914
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K862056
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/14/2023

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 Catalogue Number: AK-04301-J
• Device Lot Number: 71F21L0131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/14/2023
• Initial Date FDA Received: 10/10/2023
• Supplement Dates Manufacturer Received: 11/03/2023
• Supplement Dates FDA Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2021
• 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
• Treatment: NOT REPORTED