MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 18GA X 23CM; CATHETER PERCUTANEOUS

Catalog Number SAC-01618-PBX

Device Problems Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889)

Patient Problem Insufficient Information (4580)

Event Date 03/01/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that: "we are facing difficulties with the insertion of arterial catheters: we are recommended to insert with an angle of 30 , which is difficult in practical.Devices can kink so they cannot be used anymore.Catheters blockage are frequent." customer reported the issue occurs both during insertion and after the catheter has been placed.Customer has experienced "all types of situations" such as "patent but without return, return but without arterial curve, complete thrombosis of device".Intervention reported as "moving the catheter, change on guide, remove and re-insertion when necessary".No specific patient information was available.

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.No relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: "we are facing difficulties with the insertion of arterial catheters: we are recommended to insert with an angle of 30 , which is difficult in practical.Devices can kink so they cannot be used anymore.Catheters blockage are frequent." customer reported the issue occurs both during insertion and after the catheter has been placed.Customer has experienced "all types of situations" such as "patent but without return, return but without arterial curve, complete thrombosis of device".Intervention reported as "moving the catheter, change on guide, remove and re-insertion when necessary".No specific patient information was available.

• Brand Name: ARROW ARTERIAL CATH SET: 18GA X 23CM
• 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: 16616586
• MDR Text Key: 312282416
• Report Number: 3006425876-2023-00338
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K171146
• 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: 03/01/2023

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 Catalogue Number: SAC-01618-PBX
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/01/2023
• Initial Date FDA Received: 03/25/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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