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

Catalog Number MX6760E

Device Problem Premature Activation (1484)

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

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, the first 6/7fmynx control device get stuck in number 1 button, even when the lines were aligned.The button was not depressed.Manual compression was used to achieve hemostasis.The second 6/7f mynx control had an unknown malfunction.A third device was used for closure.There was no reported injury to the patient.The device was stored according to the instructions for use.There were no anomalies noted prior to use.The device was prepped per the ifu.There was no difficulty noted during prep.The device storage did not exceed 25°c.The deployer was certified in using the mynx man device.There was no resistance when shuttling down.Excessive force was not used while shuttling down.Unusual force was not applied when retracting the sheath.There were no kinks in the sheath or device after removal.There was no damage noted to the button.The vessel diameter was verified to be greater than 5mm in diameter.There was no presence of pvd/ calcium in the vicinity of the puncture site.The device will be returned for evaluation.

Manufacturer Narrative

As reported, the first 6f/7f mynx control device got stuck in the number 1 button, even when the lines were aligned.The button was not depressed.Manual compression was used to achieve hemostasis.The second 6/7f mynx control had an unknown malfunction.A third device was used for closure.There was no reported injury to the patient.The device was stored and prepped according to the instructions for use (ifu).There were no anomalies noted prior to use.There was no difficulty noted during prep.The device storage did not exceed 25°c.The deployer was certified in using the mynx device.There was no resistance when shuttling down.Excessive force was not used while shuttling down.Unusual force was not applied when retracting the sheath.There were no kinks in the sheath or device after removal.There was no damage noted to the button.The vessel diameter was verified to be greater than 5mm in diameter.There was no presence of peripheral vascular disease (pvd)/ calcium in the vicinity of the puncture site.Two (2) non-sterile mynx control vascular closure device 6f/7f involved in the reported complaint were returned for investigation.Visual inspection of the first device received showed that the buttons 1 and 2 were not depressed, and the sealant was in its manufactured position.Nevertheless, the sealant sleeves presented evidence of a frayed/split/torn condition that resulted in sealant exposure.Also, the balloon was fully exposed as expected due to the undepressed position observed of button 2.Additionally, the syringe used with the unit was returned for this evaluation; however, the procedural sheath was not received.A functional test was executed by depressing buttons 1 and 2 after the tension indicator achieved the deployment position, and this resulted in the correct activation of the device deployment mechanism.Per microscopic analysis, the high magnification visual analysis was done to the sealant sleeves section, where a frayed/split/torn condition was confirmed to be present along with evidence related to premature deployment/sealant exposure.The reported event of ¿button #1-frozen/locked¿ was not confirmed through analysis of the returned device as it passed functional analysis with no resistance felt.However, a condition was noted of ¿mynx control system-deployment difficulty-premature¿ as an exposure of the sealant was observed due to a frayed/split/torn condition of the sealant sleeves.Also, a second device was received for analysis and a ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ condition was noted with no exposure of the sealant.The exact cause of the issues experienced by the customer and the returned conditions of the devices could not be conclusively determined during analysis.Based on the information available for review and product analysis, it is not possible to determine what factors may have contributed to frozen/locked button 1 event experienced since both devices 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 frayed/split/torn conditions of the sealant sleeves noted with the devices (such as excessive force during insertion) and the subsequent premature exposure of the sealant for one of the devices.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 instructions for use (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 these conditions were not reported by the customer, it is unknown if these conditions 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 analyses, 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.

Event Description

As reported, the first 6/7fmynx control device get stuck in number 1 button, even when the lines were aligned.The button was not depressed.Manual compression was used to achieve hemostasis.The second 6/7f mynx control had an unknown malfunction; however, product evaluation confirmed a frayed/split/torn condition was present.A third device was used for closure.There was no reported injury to the patient.The device was stored according to the instructions for use.There were no anomalies noted prior to use.The device was prepped per the ifu.There was no difficulty noted during prep.The device storage did not exceed 25°c.The deployer was certified in using the mynx man device.There was no resistance when shuttling down.Excessive force was not used while shuttling down.Unusual force was not applied when retracting the sheath.There were no kinks in the sheath or device after removal.There was no damage noted to the button.The vessel diameter was verified to be greater than 5mm in diameter.There was no presence of pvd/ calcium in the vicinity of the puncture site.The device will be returned for evaluation.

• 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, california 95054 ; 7863138372
• MDR Report Key: 19192387
• MDR Text Key: 341260256
• Report Number: 3004939290-2024-00210
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: MX6760E
• Device Lot Number: F2302501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/25/2023
• 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