MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC KIT: 16 GA X 20 CM; CATHETER, PERCUTANEOUS

Catalog Number ASK-04301-KR

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

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 10/03/2023

Event Type  malfunction  

Event Description

It was reported that the user felt difficulty when removing the spring wire guide (swg) from the catheter after insertion, because of resistance.He/she managed to remove the swg, and found it torn.The patient bled "more frequent than usual", but no injury to the patient occurred.A ct scan was performed and nothing remained in the patient.The patient's condition is reported as fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn#(b)(4).The customer returned one swg and the product lidstock for evaluation.The catheter was not returned.The guide wire was unraveled and showed evidence of use.Visual examination revealed the guide wire was unraveled towards the distal end.The distal end of the core wire was broken and protruding out of the coil wire.The distal j-bend was misshapen but intact.Microscopic examination of the guide wire confirmed the core wire was broken near the distal weld.The exposed core wire tips were pinched at the points of separation.Both welds appeared full and spherical.The core wires were still attached to both welds.Visual inspection of the catheter could not be performed as the catheter was not returned.The proximal portion of the broken core wire measured 580mm in length while the distal portion of the broken core wire measured 22mm.The total length of the core wires measured 602mm, which is within the specifications of 596-604 mm per guide wire product drawing; therefore, no pieces of the core wire appear to be missing.The outside diameter of the guide wire measured 0.794 mm which is within specifications of 0.788-0.826 mm per guide wire product drawing.Functional inspection of the guide wire could not be performed for this complaint investigation due to the damage to the returned guide wire.A manual tug test confirmed that the proximal and distal welds were intact.A device history record review was performed on the guide wire and catheter and no relevant manufacturing issues were identified.The instructions for use (ifu) provided with this product describes suggested techniques to minimize the likelihood of guide wire damage during use.The ifu cautions that if resistance is encountered when attempting to remove the spring-wire guide after catheter placement, the spring-wire may be kinked about the tip of the catheter within the vessel which may result in undue force being applied resulting in spring wire guide breakage.If resistance is encountered, withdraw the catheter relative to the spring-wire guide about 2-3 cm and attempt to remove the spring-wire guide.If resistance is again encountered, remove the spring-wire guide and catheter simultaneously.The report that the guide wire was unraveled was confirmed through examination of the returned sample.The guide wire core wire was broken towards the distal end.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, however, the probable cause of guide wire and catheter resistance could not be determined based upon the information provided and without the catheter being returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that the user felt difficulty when removing the spring wire guide (swg) from the catheter after insertion, because of resistance.He/she managed to remove the swg, and found it torn.The patient bled "more frequent than usual", but no injury to the patient occurred.A ct scan was performed and nothing remained in the patient.The patient's condition is reported as fine.

• Brand Name: ARROW CVC KIT: 16 GA 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: 18005709
• MDR Text Key: 326523300
• Report Number: 3006425876-2023-01008
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/03/2023

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: ASK-04301-KR
• Device Lot Number: 71F22F5200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/25/2023
• Supplement Dates Manufacturer Received: 11/20/2023
• Supplement Dates FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2022
• 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