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

Catalog Number MX6760

Device Problem Premature Activation (1484)

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

Event Date 11/17/2023

Event Type  malfunction  

Event Description

As reported, (2) 6/7f mynx control vascular closure devices (vcd) split and the balloon was unable to inflate during prep no matter the force exerted to do so.Manual compression was held.There was no reported patient injury.After seeing the device, the sales representatives states that there is no split in the device.The balloons themselves would not inflate and were unable to be prepped and the white-black-white bumper would not be exposed no matter how much force was provided.Neither device was used in the patient as they were unable to get the devices to prep properly.A 6f 11 cm cordis sheath was used.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the 6f vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was no vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The mynx vcd was used in interventional procedure with a retrograde approach use.The user was mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The devices will be returned for evaluation.Addendum: per the product evaluation for complaint 1, the sealant was present as expected in manufacturing position partially exposed due to the sealant sleeves conditions that showed light deformations evidence on the outer sleeves surface that could be perceived as a kinked condition.

Manufacturer Narrative

Complaint conclusion: as reported, two (2) 6f/7f mynx control vascular closure devices (vcd) split and the balloon was unable to inflate during prep no matter the force exerted to do so.Manual compression was held.There was no reported patient injury.After seeing the device, the sales representatives state that there is no split in the device.The balloons themselves would not inflate and were unable to be prepped and the white-black-white bumper would not be exposed no matter how much force was provided.Neither device was used in the patient as they were unable to get the devices to prep properly.A 6f 11 cm cordis sheath was used.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the 6f vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was no vessel tortuosity.There was no presence of calcium in the vicinity of the puncture site.The mynx vcd was used in interventional procedure with a retrograde approach use.The user was mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.(b)(4): a non-sterile 6f/7f mynx control vascular closure device (vcd) involved in the reported complaint was returned for investigation.Visual inspection of the device showed that the buttons 1 and 2 were not depressed, and the stopcock was found opened.The sealant was present as expected in its manufactured position partially exposed since the condition of the sealant sleeves showed evidence of light deformations on the outer sleeves surface that could be perceived as a kinked condition.Neither the syringe nor the catheter sheath introducer (csi) used were returned for this evaluation.No additional anomalies were observed during this analysis.Functional testing was executed using a cordis lab syringe, and the reported balloon malfunction was not confirmed with any evidence that could be related to such malfunction as the balloon could be inflated and deflated as expected per device use.Due to the sealant exposure observed, the sealant deployment mechanism was tested.During this analysis, it was observed that no issues with the deployment mechanism could be confirmed as the sealant was deployed after both buttons (1 & 2) were depressed.Per microscopic analysis, a magnified visual analysis of the sleeves surface was executed to evaluate the sleeves condition.During this analysis a premature exposure of the sealant was confirmed.The reported event of ¿balloon-inflation difficulty¿ was not confirmed through analysis of the returned device since the balloon was able to be inflated during functional analysis.However, conditions were noted in the returned device of ¿sealant sleeves (cartridge assembly)-kinked/bent¿ and ¿mynx control system-deployment difficulty-premature¿ as an exposure of the sealant was observed due to the kinked/bent condition of the sealant sleeves noted.The exact cause of the issue experienced could not be determined during analysis.Based on the information available for review and product analysis, it is difficult to determine what factors may have contributed to the issues experienced.However, prepping factors may have contributed to the balloon inflation difficulty reported since there were no anomalies noted during functional analysis.Additionally, prepping/handing factors likely contributed to kinked/bent 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 sealant is placed right under the outer sleeve assembly and is protected from exposing prematurely.The outer sleeve is assembled with 2 side slit overlapping outer sleeves.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, that could cause the sealant to be exposed/swollen prematurely.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.As warned in the ifu, ¿do not use if components or packaging appear to be damaged or defective or if any portion of the packaging has been previously opened.¿ the ifu also stated during preparation, ¿prepare balloon: fill locking syringe with 2 to 3 ml of sterile saline, attach to stopcock and draw vacuum.Check luer connector and tighten if necessary.Inflate the balloon until the black marker on the inflation indicator is fully visible.Check for leaks in the balloon and 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.Deflate the balloon and leave syringe at neutral.Do not lock.¿ 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: 18808328
• MDR Text Key: 337626786
• Report Number: 3004939290-2024-00088
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/29/2024

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: MX6760
• Device Lot Number: F2312907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/13/2024
• Initial Date FDA Received: 02/29/2024
• 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
• Treatment: 6F 11CM CORDIS BRITE TIP SHEATH 401611M.
• Patient Age: 86 YR
• Patient Sex: Female