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

Catalog Number	AK-04301-J
Medical Device Problem Codes	Unraveled Material (1664); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).
Additional 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.
Event or Problem 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.
Additional Manufacturer Narrative
(b)(4).In section d provided the full udi # udi related data quality updates only.
Event or Problem 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.

• Brand Name: ARROW CVC KIT: 1-LUMEN 5 FR X 20 CM
• Common Device Name: 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: marling heaton ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 17903674
• Report Number: 3006425876-2023-00967
• Device Sequence Number: 7701180
• Product Code: DQY
• UDI-Device Identifier: 00801902101914
• UDI-Public: (01)00801902101914(11)211103(17)250331(10)71F21L0131(21)
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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 Expiration Date: 03/31/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2023
• Supplement Date Received by Manufacturer: 11/03/2023; Not provided
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/06/2023; 07/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/03/2021
• 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