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

Catalog Number MX5060

Device Problem Premature Activation (1484)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the shaft of a 5f mynx control vascular closure device (vcd) cracked, and the plug deployed prematurely.There was no reported patient injury.There was no exposure of the sealant to bodily fluids.The sealant was prematurely exposed during insertion into the sheath.The user is trained to the device.Another unknown mynx device was used to complete the procedure.The device was stored and prepped according to instructions for use (ifu).Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returning for evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3 and h6.As reported, the shaft of a 5f mynx control vascular closure device (vcd) cracked, and the plug deployed prematurely.There was no reported patient injury.There was no exposure of the sealant to bodily fluids.The sealant was prematurely exposed during insertion into the sheath.The user was trained to the device.Another unknown mynx device was used to complete the procedure.The device was stored and prepped according to instructions for use (ifu).Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.A non-sterile mynx control vascular closure device 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 sealant remained in its manufactured position and exposed from the sealant outer sleeve assembly, which were observed with a frayed/split/torn condition as received during this unaided eye visual inspection.The syringe used was attached to the unit; however, the procedural sheath was not received.The dimensional analysis of the slit length could not be measured due to the observed frayed/split/torn conditions.Due to the premature exposure of the sealant, a deployment functional analysis was performed.During this analysis, the deployment mechanism was tested by depressing both buttons (1&2), resulting in the correct sealant deployment and balloon retraction.Per microscopic analysis, visual inspection at high magnification, showed that the sealant outer sleeve assembly presented evidence of a frayed/split/torn condition.Nevertheless, there were no cracked-related conditions observed.Meanwhile the sealant was observed to be prematurely exposed due to the conditions reported on the device.The reported event of ¿sealant sleeves (cartridge assembly)-cracked¿ was not confirmed through analysis of the returned device since there were no cracks observed; however, a frayed/split/torn condition of the sleeves was noted.Also, the reported event of ¿mynx control system-deployment difficulty-premature¿ was confirmed due to the exposed sealant from the frayed/split/torn 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 issues experienced.However, procedural/handling factors (such as using excessive force during insertion into the sheath and/or using an incorrect insertion angle), access site vessel characteristics (mild tortuosity) and/or the condition of the procedural sheath (although not returned) possibly contributed to the damaged 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 assembly 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/shredded 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 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: 18921068
• MDR Text Key: 337864150
• Report Number: 3004939290-2024-00124
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 20862028000424
• UDI-Public: 20862028000424
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040044
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/08/2024

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: MX5060
• Device Lot Number: F2317901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• 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: 03/18/2024
• Supplement Dates Manufacturer Received: 05/02/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/2023
• 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: UNKNOWN MYNX