MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 2-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Catalog Number CV-17702-E

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

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

Event Date 11/24/2023

Event Type  malfunction  

Event Description

It was reported "the swg tangles on the needle.It wont move forward or backwards.Its needed to take out all the needle and ask for a new cvc kit".No patient harm or injury.No medical intervention required.The patient's current condition reported as "fine".

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The customer returned one guide wire and one 18 ga introducer needle, as well as the product lidstock, for analysis.The guide wire was returned within its advancer tubing and was partially advanced through the needle.Signs of use in the form of dried biomaterial were observed on the returned components.Visual inspection of the returned guide wire revealed one kink in its body.Microscopic examination confirmed the damage.The distal j-bend was misshapen.Both welds were observed to be present and appeared to be full and spherical.After performing functional testing, significant amounts of dried biomaterial were observed accumulated on the portion of the guide wire that was threaded through the needle.The kink in the guide wire measured 22mm from the distal end.The total length of the guide wire measured 603mm, which is within the specifications of 596-604mm per product drawing.The guide wire outer diameter measured 0.80mm, which is within the specifications of 0.788-0.826mm per product drawing.The needle cannula outer diameter measured 0.0501" which is within the specifications of 0.0495"-0.0505" per product drawing.Once the blockage was cleared, the needle cannula inner diameter measured 0.041", which is within the specifications of 0.041"-0.043" per product drawing.Functional inspection of the guide wire was performed per the instructions for use (ifu) provided with the kit which states, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." resistance was observed while attempting to retract the guide wire through the needle.Significant amounts of biomaterial were observed on the portions of the guide wire that were stuck inside the needle.Once the blockage was cleared, the guide wire was re-threaded through the needle with no resistance.This indicates that the accumulation of biomaterial was the likely cause of the resistance within the needle cannula.A manual tug test confirmed the distal and proximal welds were intact on the guide wire.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit warns the user, "warning: do not withdraw guidewire against needle bevel to reduce risk of possible severing or damaging of guidewire." the customer report of a kinked guide wire was confirmed through complaint investigation of the returned sample.Visual inspection revealed a kink in the guide wire body.Resistance was observed between the guide wire and needle, which was caused by an accumulation of biomaterial within the cannula.The returned guide wire and needle met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on these circumstances, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

It was reported "the swg tangles on the needle.It wont move forward or backwards.Its needed to take out all the needle and ask for a new cvc kit".No patient harm or injury.No medical intervention required.The patient's current condition reported as "fine".

• Brand Name: ARROW CVC SET: 2-LUMEN 7 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: 18681402
• MDR Text Key: 335046982
• Report Number: 3006425876-2024-00104
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K862056
• 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: 01/22/2024

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: CV-17702-E
• Device Lot Number: 14F23B0284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/22/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 03/15/2024
• Supplement Dates FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2023
• 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: NONE REPORTED.; NONE REPORTED.