MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 16 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-22703-E

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Date 11/08/2023

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that "during the procedure according to ifu, md found that during guide wire bent.So md opened up the new kit to finish the procedure." there was no reported patient harm or consequence.

Event Description

It was reported that "during the procedure according to ifu, md found that during guide wire bent.So md opened up the new kit to finish the procedure." there was no reported patient harm or consequence.

Manufacturer Narrative

Qn# (b)(4).The customer report of a kinked guide wire could not be confirmed through complaint investigation of the returned sample.The customer returned one opened cvc set with multiple components, including a guide wire, for analysis.The guide wire was returned within its advancer tube and showed evidence of use.Visual inspection of the guide wire revealed no obvious defects or anomalies.No visible kinks were observed on the guide wire.The distal j-bend was present and appeared intact.Both welds were present and appeared full and spherical.The guide wire total length measured 456mm via calibrated ruler, which was within the specifications of 450-458mm per product drawing.The guide wire outer diameter (od) measured 0.79mm via calibrated caliper, which was within the specifications of 0.788-0.826mm 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." the guide wire was able to pass through the returned arrow raulerson syringe (ars) and a lab inventory introducer needle with no resistance.A manual tug test confirmed the distal and proximal welds were intact.The instructions-for-use (ifu) provided with the kit describes suggested techniques to minimize the likelihood of guide wire damage during use.The instructions caution that withdrawing the guide wire against the needle bevel or use of excessive force during removal could damage or break the wire.A device history record review was performed on the guide wire and no relevant manufacturing issues were identified.Based on these circumstances, no problem was found with the returned sample.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 16 CM
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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: kevin don bosco ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18289786
• MDR Text Key: 330005563
• Report Number: 3006425876-2023-01203
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K900263
• 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: 11/13/2023

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: 02/29/2024
• Device Catalogue Number: CS-22703-E
• Device Lot Number: 71F22C1453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/29/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/08/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2022
• 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.