MAUDE Adverse Event Report: CARDINAL HEALTH SANTA CLARA MYNX CONTROL; DEVICE, HEMOSTASIS, VASCULAR

Catalog Number MX5060E

Device Problem Premature Activation (1484)

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

Event Date 12/01/2023

Event Type  malfunction  

Event Description

As reported, the sealant protection tip of a 5f mynx control vascular closure device (vcd) was damaged.The tip was bent before the procedure.There was no reported patient injury.The device was used in a transcatheter arterial chemoembolization (tace) procedure.The device will be returned for evaluation.Addendum: pe findings present the sealant exposed.

Manufacturer Narrative

As reported, the sealant protection tip of a 5f mynx control vascular closure device (vcd) was damaged.The tip was bent before the procedure.There was no reported patient injury.The device was used in a transcatheter arterial chemoembolization (tace) procedure.Multiple attempts to obtain additional information were made without success.A non-sterile ¿mynx control vcd 5f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that button 1 and button 2 were not depressed.The syringe and the procedural sheath were not returned for evaluation.The stopcock was found opened.The sealant was found partially exposed from the sealant sleeves, which were observed to have been severely kinked/bent as received; however, no cracks were observed on it.Dimensional analysis could not be performed on the returned device due to the severely kinked/bent sealant sleeve assembly condition.Per functional analysis, a simulated deployment test was performed on the returned device per the mynx control instructions for use (ifu), button 1 was able to be fully depressed and locked in place with some resistance felt.It was revealed that the sealant was exposed to blood which caused the resistance felt when attempting to depress the button 1.Button 2 was able to be fully depressed, and no issues were noted with respect to button 2.Per microscopic analysis, visual inspection at high magnification revealed that the sealant was found partially exposed from the sealant sleeves due to the severely kinked/bent sleeves as received with no cracks observed on it.The reported event of ¿sealant sleeves (cartridge assembly)-kinked/bent¿ was confirmed through analysis of the returned device as the sleeves were found to be severely kinked/bent as received.Additionally, a condition was noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ due to the partially exposed sealant from the kinked sleeves.The exact cause of the observed conditions could not be conclusively determined during analysis.Based on the limited information available for review and product analysis, it is difficult to determine what factors may have contributed to the issue experienced.However, procedural/handling factors (such as excessive force during insertion and/or incorrect insertion angle), and/or the condition of the sheath (although not returned) possibly contributed to the kinked condition of the sealant sleeves, and the subsequent premature exposure of the sealant.It should be noted that the mynx control device is manufactured with a slit at the end of the catheter cartridge tubing.The outer sleeve is assembled with 2 side slit overlapping outer sleeves.The sealant is placed right under the outer sleeve assembly and is protected from exposing prematurely.The slits on the outer sleeve assembly are designed to decrease unsheathing force and increase deployment reliability.Refer to the diagram of the mynx control vcd within the ifu displaying the sealant sleeve with slit.If the outer sleeve is damaged/kinked during prepping phase and/or insertion into sheath, it could cause the sealant to be exposed/swollen prematurely and/or obstruct the device path and prevent the device from being inserted into the procedural sheath.As warned in the ifu, which is not intended as a mitigation, ¿do not use if components or packaging appear to be damaged or defective or if any portion of the packaging has been previously opened.¿ additionally, the ifu states ¿step 1: position balloon, insert the mynx control vcd into the procedural sheath through the sheath valve.Advance the catheter until the sheath catch nears the hub of the sheath.Rotate the sheath catch as needed to hook onto the side port of the procedural sheath.¿ neither the product analysis, nor the information available for review suggest that the failures noted could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

• Brand Name: MYNX CONTROL
• Type of Device: DEVICE, HEMOSTASIS, VASCULAR
• Manufacturer (Section D): CARDINAL HEALTH SANTA CLARA; 5452 betsy ross drive; santa clara CA 95054
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, CA 95054 ; 7863138372
• MDR Report Key: 18820848
• MDR Text Key: 337316258
• Report Number: 3004939290-2024-00095
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2024

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 Operator: Health Professional
• Device Catalogue Number: MX5060E
• Device Lot Number: F2220601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2022
• 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