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

Model Number N/A

Device Problem Premature Activation (1484)

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

Event Date 12/08/2023

Event Type  malfunction  

Event Description

As reported, button one of two mynx control vascular closure devices (vcds) was not able to be depressed by the physician.The sales rep opened a third device and tested it outside the procedure room and that device deployed without issue.There was no reported patient injury.The user is mynx certified.The balloon was prepped with 50/50 contrast.There was no balloon inversion or detachment.The two used devices, as well as the tested device, will be returned for evaluation.Devices later returned included a fourth device that after investigation with site, were unable to confirm reason for return of fourth device.Addendum: product analysis for second device demonstrates that the sealant was found exposed from the sealant sleeves assembly due it was observed to have been severely kinked/bent outward as received.

Manufacturer Narrative

As reported, button one of two mynx control vascular closure devices (vcds) was not able to be depressed by the physician.The sales rep opened a third device and tested it outside the procedure room and that device deployed without issue.There was no reported patient injury.The user is mynx certified.The balloon was prepped with 50/50 contrast.There was no balloon inversion or detachment.The two used devices, as well as the tested device, will be returned for evaluation.Devices later returned included a fourth device that after investigation with site, were unable to confirm reason for return of fourth device.A non-sterile ¿mynx control vcd 6f-7f¿ 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 with the stopcock opened and the balloon fully deflated.The syringe was not received for evaluation, and a cordis procedural sheath was returned locked onto the sheath catch.Blood was noted in the procedure sheath, and no damages were observed on it.The sealant was found exposed from the sealant sleeves assembly, which was observed to have been severely kinked/bent outward as received.Per functional analysis, a simulated deployment test was performed on the returned device per the mynx control ifu, step 2: deploy sealant.Button 1 was able to be depressed to deploy the sealant with no resistance felt.No issues were noted with respect to button 1 deployment during the device failure investigation, and the returned device performed as intended per the mynx control ifu.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 showed that the sealant was found exposed from the sealant sleeves assembly due to the severely kinked/bent outward condition as received.The reported events of ¿button #1-frozen/locked¿ was not confirmed through analysis of all four returned devices as they passed functional analysis with no resistance felt.However, a condition was noted in the device received under the second complaint of ¿mynx control system-deployment difficulty-premature¿ as an exposure of the sealant was observed due to the severely kinked/bent condition of the sealant sleeves noted.The exact cause of the issues experienced by the customer and the premature exposure of the sealant 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 frozen/locked button 1 events experienced since they were able to be fully depressed during functional analysis with no resistance felt.However, handling factors (such as incorrect alignment of the tension indicator prior to attempting depression) are possible.Additionally, procedural/handling factors possibly resulted in the kinked/bent condition of the sealant sleeves noted with the second device (such as excessive force during insertion) 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.However, as this condition was not reported by the customer, it is unknown if this condition occurred during use in the procedure.Although not intended as a mitigation of risk, the information for safety within the ifu is provided in the product¿s labeling with the intent to make the user aware of the risks.According to the mynx control ifu, ¿grasp the device handle and align the device with the tissue tract.Pull gently to retract the device until the black line in the tension indicator window aligns with the markers on the side, indicating the balloon is abutting the arteriotomy with the correct amount of tension.While maintaining tension press button #1 until it is fully aligned with the handle, and the clock symbol is visible in the tension indicator window.¿ the ifu also warns, ¿do not use if components or packaging appear to be damaged or defective or if any portion of the packaging has been previously opened.¿ neither the product analysis, nor the information available for review suggest that the issues experienced could be related to the design or manufacturing process of the units.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: 18987226
• MDR Text Key: 338719341
• Report Number: 3004939290-2024-00145
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• UDI-Public: 10862028000410
• 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
• Report Date: 03/27/2024

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 Model Number: N/A
• Device Catalogue Number: MX6760
• Device Lot Number: F2312907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2024
• Initial Date FDA Received: 03/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2023
• 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