MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 22 GA X 4" (10 CM); CATHETER PERCUTANEOUS

Catalog Number ES-04522-BZ

Device Problems Material Rupture (1546); Unraveled Material (1664)

Patient Problem Insufficient Information (4580)

Event Date 09/06/2023

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).

Event Description

The physician reported she inserted the needle and guidewire using ultrasound guidance, at a 30-degree angle.When trying to remove the needle, it didn't come out because it was stuck to the guidewire.After a few unsuccessful attempts to remove it, she found that the wire spring was opening, coming apart (fraying).She removed the set to avoid further complications, lost the puncture and used another needle and guidewire (from another supplier) to place the catheter.

Event Description

The physician reported she inserted the needle and guidewire using ultrasound guidance, at a 30-degree angle.When trying to remove the needle, it didn't come out because it was stuck to the guidewire.After a few unsuccessful attempts to remove it, she found that the wire spring was opening, coming apart (fraying).She removed the set to avoid further complications, lost the puncture and used another needle and guidewire (from another supplier) to place the catheter.

Manufacturer Narrative

Qn# (b)(4).The customer provided one photo for analysis.The image shows an unraveled guidewire partially advanced through a needle.The customer also returned one straight guide wire and a 21ga introducer needle for evaluation.The guide wire was returned advanced through the needle cannula.Signs of use in the form of dried blood were observed on the returned components.Visual examination revealed the guide wire was unraveled and the proximal portion of the guide wire was stuck within the introducer needle.There were several kinks throughout the guide wire body.The guide wire was unraveled towards the proximal end.Undue force was used to remove the guide wire from the introducer needle and the guide wire separated into two parts.The returned introducer needle did not show obvious defects or anomalies.Microscopic examination of the guide wire confirmed the core wire was broken adjacent to the proximal weld.The exposed proximal core wire tip was tapered and discolored at the point of separation.Both welds were present and appeared full and spherical.The broken core wire measured 35.4 cm which is within the specification limits of 34.4-35.6 cm per the guide wire product drawing.The outer diameter of the guide wire measured 0.02000" which is within the specification limits of 0.020" - 0.021" per the gu ide wire product drawing.The outer diameter of the needle cannula measured 0.03205", which is within the specification limits of 0.0320"-0.0325" per the needle cannula product drawing.The inner dia meter of the needle cannula measured 0.024" which is within the specification limits of 0.0225"-0.0240" per the needle cannula product drawing.After removal of the guide wire from the needle, a blockage was observed during functional testing.A long pin gauge was used to push out biological material buildup.After clearing the blockage, the returned guide wire was advanced through the returned introducer needle and functionally tested per the instructions for use (ifu) provided with this kit, which states "insert desired tip of spring-wire guide through introducer needle or catheter into vein." the guide wire was able to advance through the returned introducer needle with little to no resistance.Prior to using undue force to remove the guide wire from the introducer needle, a manual tug test confirmed that the distal weld was secure and intact, and the core wire was broken towards the proximal weld.A device history record review was performed, and there were no relevant findings.The instructions for use (ifu) provided with the kit warns the user, "warning: do not apply excessive force in removing guide wire or catheters.If withdrawal cannot be easily accomplished, a chest x-ray should be obtained and further consultation requested." the report that the guide wire unraveled was confirmed through examination of the returned sample.The core wire was broken adjacent to the proximal weld.The guide wire and introducer needle met all functional and 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 2.0 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 caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW CVC SET: 22 GA X 4" (10 CM)
• Type of Device: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18000232
• MDR Text Key: 326467443
• Report Number: 9680794-2023-00789
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K810962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

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 Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Catalogue Number: ES-04522-BZ
• Device Lot Number: 14F19F0313
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/29/2023
• Initial Date FDA Received: 10/24/2023
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2019
• 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.; NOT REPORTED.