MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER INTRAVASCULAR THERAPE

Catalog Number CS-25703-E

Device Problem Material Twisted/Bent (2981)

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

Event Date 03/31/2024

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported "swg kinking".This was found prior to use therefore no patient harm or injury.

Event Description

It was reported "swg kinking".This was found prior to use therefore no patient harm or injury.

Manufacturer Narrative

Qn#(b)(4).The customer returned one guide wire within its advancer and a 3-lumen catheter for analysis.The guide wire cap was not returned.Signs of use were observed on the guide wire and within the advancer tubing; however, the customer stated, "the biological matters were transferred during handling.Kinking was observed before used on the patient." visual analysis of the guide wire revealed multiple kinks towards the distal end and multiple bends throughout the body.Microscopic examination confirmed the kinks in the guide wire body.Both welds were present and were observed to be full and spherical.No defects or anomalies were observed on the returned packaging.The major kinks in the guide wire measured 8 mm, 21 mm, 30 mm, and 39 mm from the distal tip.The overall length of the guide wire measured 602 mm, which is within the specification limits of 596-604 mm per guide wire product drawing.The outer diameter of the guide wire measured 0.807 mm, which is within the specification limits of 0.788-0.826 mm per guide wire product drawing.The guide wire was functionally tested per the instructions-for-use (ifu).The ifu provided with this kit instructs the user, "advance guidewire into arrow raulerson syringe approximately 10 cm until it passes through syringe valves or into introducer needle." the guide wire was advanced through a lab inventory arrow raulerson syringe and 18ga introducer needle.The undamaged portions of the guide wire passed through both components with little to no resistance.A manual tug test confirmed that both the distal and proximal welds were intact.A device history record review was performed, and no relevant findings were identified.The ifu provided with this kit warns the user, "do not use if package is damaged.Do not use if package is damaged.Do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage." the report that the guide wire was kinked was confirmed through complaint investigation of the returned sample.Multiple kinks were observed towards the distal end of the guide wire body.The guide wire met all relevant dimensional and functional requirements, and a device history record review was performed with no relevant findings to suggest a manufacturing related cause.The portion of the guide wire that was kinked would have been protected within the assembly tubing during packaging, storage, and shipping, so it cannot be confirmed when the guide wire was damaged.In addition, there was a discrepancy between the customer report (damage prior to use) and the returned sample (evidence of use on the guide wire).Based on these circumstances, the root cause of this investigation is undetermined.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 19200738
• MDR Text Key: 341357290
• Report Number: 3006425876-2024-00389
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801902102324
• UDI-Public: 00801902102324
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K900263
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/01/2024

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: CS-25703-E
• Device Lot Number: 71F23B1973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/01/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2023
• 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