MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW ARTERIAL CATH SET: 18GA X 16CM; CATHETER, PERCUTANEOUS

Catalog Number SAC-01618

Device Problems Difficult to Remove (1528); Unraveled Material (1664); Deformation Due to Compressive Stress (2889)

Patient Problem Discomfort (2330)

Event Date 09/27/2023

Event Type  malfunction  

Event Description

It was reported that: obese male patient in hemorrhagic shock with need of constant arterial pressure monitoring.3 attempts with 3 different sets.They were unable to remove the swg from the vessel without the swg unravelling.Associated complaints: tc# (b)(4) for device #1, tc# (b)(4) for device #2, tc# (b)(4) for device #3.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Qn# (b)(4).The report of a damaged guide wire could not be confirmed through investigation of the returned sample.The customer returned one unopened sac kit for analysis.Visual analysis revealed no obvious defects or anomalies with the returned kit.The customer reported that the damage was found during use on the patient.Therefore, it is being assumed that the unopened kit returned for analysis is a representative sample.The kit was opened to further analyse the components.The guide wire length measured 456mm via calibrated ruler, which was within the specification limits of 450-458 mm per the guide wire product drawing.The guide wire outer diameter measured 0.618mm via calibrated micrometer, which was within the specification limits of 0.610-0.635 mm per the guide wire product drawing.Dimensional inspection of the actual guide wire could not be performed as it was not returned for evaluation.The guide wire was functionally tested per the instructions for use (ifu) provided with this kit, which states "insert desired tip of spring-wire guide through introducer needle into artery (until depth-marking [if provided] on wire enters hub of needle)." the guide wire was inserted through the returned 18ga introducer needle.The guide wire was able to pass through the needle with little to no resistance.Functional inspection of the actual guide wire could not be performed as it was not returned for evaluation.A manual tug test confirmed that the distal and proximal welds were secure and intact.The ifu provided with the kit informs the user, "precaution: use care when removing spring-wire guide.If resistance is encountered, remove spring-wire guide and catheter simultaneously.Use of excessive force may damage catheter or spring-wire guide." a device history record review was performed, and no relevant findings were identified.Based on the customer report and without the reported sample, the potential root cause cannot be determined at this time.Tele flex will continue to monitor and trend for reports of this nature.

Event Description

It was reported that: obese male patient in hemorrhagic shock with need of constant arterial pressure monitoring.3 attempts with 3 different sets.They were unable to remove the swg from the vessel without the swg unravelling.Associated complaints: tc# (b)(4) for device #1.Tc# (b)(4) for device #2.Tc# (b)(4) for device #3.

Manufacturer Narrative

Qn#(b)(4).

Event Description

It was reported that: obese male patient in hemorrhagic shock with need of constant arterial pressure monitoring.3 attempts with 3 different sets.They were unable to remove the swg from the vessel without the swg unravelling.Associated complaints: - tc# (b)(4) for device #1.- tc# (b)(4) for device #2.- tc# (b)(4) for device #3.

• Brand Name: ARROW ARTERIAL CATH SET: 18GA X 16CM
• 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: laura guadalupe gonzalez ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 18056977
• MDR Text Key: 327263228
• Report Number: 3006425876-2023-01034
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K093050
• 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,Followup
• Report Date: 10/10/2023

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
• Device Lot Number: 71F20D1523
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2023
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/10/2023
• Initial Date FDA Received: 11/02/2023
• Supplement Dates Manufacturer Received: 11/27/2023; Not provided
• Supplement Dates FDA Received: 11/28/2023; 07/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/30/2020
• 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; NOT REPORTED