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

Catalog Number MX5060E

Device Problems Premature Activation (1484); Decrease in Pressure (1490); Material Rupture (1546); Mechanical Jam (2983)

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

Event Date 08/24/2023

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.

Event Description

As reported, a 5f mynx control vascular closure device (vcd) had an inflation indicator problem.There was no reported patient injury.Additional information was requested but not provided.The device was later returned for evaluation as previously expected.Addendum: product evaluation shows a leak in the balloon and that the sealant was found partially exposed from the sealant sleeves and button #2 was not able to be fully depressed, which may have contributed to the balloon not completely withdrawing into the tube.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: d2, g1, g3, g6, h1, h2, h3 and h6.As reported, a 5f mynx control vascular closure device (vcd) had an inflation indicator problem.There was no reported patient injury.Additional information was requested but not provided.A non-sterile ¿mynx control vcd 5f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that both button 1 and button 2 were not depressed.The procedural sheath and the syringe were not returned, and the stopcock was observed opened.In addition, the balloon was found fully deflated; however, it was noted that there were crystallized residuals on it.The sealant was found partially exposed from the sealant sleeves and exposed to blood.No damages were observed to the pressure gauge or the sealant sleeves.The device was inspected for damages/anomalies that may have contributed to the reported failure and no damages/anomalies were observed on the returned device.Per functional analysis, an inflation/deflation test was performed per the mynx control instructions for use (ifu).The results revealed a leak in the balloon of the returned device.In addition, a simulated deployment test was performed on the returned device per the 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.However, button #2 was not able to be fully depressed since it was noted that on the balloon had crystallized residuals, which may have contributed to the balloon not being completely withdrawn into the tube.Per microscopic analysis, visual inspection at high magnification revealed a micro tear in the balloon of the return device and crystallized residual on it.The sealant was found partially exposed from the sealant sleeves and exposed to blood.No damages were observed to the sleeves.The reported event of ¿pressure gauge-damaged¿ could not be confirmed since the mechanism could not be tested due to the additional condition of ¿balloon-balloon loss of pressure¿ that was noted during functional analysis due to a micro tear in the balloon.Additionally, conditions were noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ due to the exposed sealant that was swelled from blood exposure, and ¿button 2-frozen/locked¿ since the balloon could not be completely retracted due to the crystallized residuals on the balloon.However, the exact cause of the issues experienced could not be conclusively determined during analysis.Based on the limited information available for review and product analysis, it is not possible to determine what factors may have contributed to the issues noted.However, in regard to the inflation indicator issue reported, it is possible that the issue experienced was related to the micro tear found in the balloon, which would have resulted in issues with the inflation indicator.Prepping/handling factors, access site vessel characteristics (although not reported) and/or concomitant device factors (although not returned) most likely contributed to the micro tear noted since excessive force, a calcified vessel, and/or concomitant device factors (such as a damaged procedural sheath, stent, or vascular graft) can cause damage to the balloon and result in a loss of pressure.Regarding the issues experienced during functional analysis of button 2, the inability to fully retract the balloon into the tamp tube and fully depress button 2 was likely due to the crystallized solution with the deflated balloon.However, this condition was unlikely to have occurred during use of the device by the customer as the saline solution would not likely have been crystallized when attempting to use this mechanism.Also, procedural/handling factors possibly contributed to the premature exposure/swelling 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 slits are designed to decrease unsheathing force and increase deployment reliability.The sealant is placed right under the outer sleeve assembly and is protected from exposing prematurely.Refer to the diagram of the mynx control vcd within the ifu displaying the sealant sleeve with slit.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.The ifu states, ¿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, ¿confirm via femoral arteriogram: common femoral artery single wall puncture.Evidence of adequate flow.No evidence of significant pvd in the vicinity of the puncture.¿ also, the device preparation states, "inflate the balloon until the black marker on the inflation indicator is fully visible.Check for leaks in the balloon and the syringe connector; retighten if necessary.Discard the device if the balloon does not maintain pressure.Check for air bubbles in the balloon.If air bubbles are visible, deflate the balloon, draw vacuum to remove bubbles and re-inflate.¿ 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: 18461471
• MDR Text Key: 332735676
• Report Number: 3004939290-2024-00011
• Device Sequence Number: 1
• Product Code: MGB
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/07/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MX5060E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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