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

Catalog Number MX6760

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

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

Event Date 09/12/2023

Event Type  malfunction  

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, the balloon of a 6/7f mynx control vascular closure device (vcd) ruptured.There was no reported patient injury.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.

Manufacturer Narrative

Complaint conclusion: as reported, the balloon of a 6f/7f mynx control vascular closure device (vcd) ruptured.There was no reported patient injury.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.A non-sterile ¿mynx control vcd, 6f/7f¿ involved in the reported complaint was returned for product investigation.Per visual analysis, the unit was thoroughly inspected observing that both button 1 and button 2 were not depressed, and the balloon was exposed and not retracted.The syringe and a cordis procedural sheath were returned for analysis.The stopcock was set in the open position.The sealant remained in its manufactured position, swelled by the blood saturation and exposed.The atraumatic tip did not present any damages or anomalies.The device was blood saturated.No other outstanding details were noticed.Per functional analysis, an inflation/deflation test was performed on the returned device to ensure the balloon¿s functionality according to the instructions for use (ifu).The results revealed a leak in the balloon.Per microscopic analysis, the balloon was inspected using a vision system to obtain a magnified image, and the pin hole was confirmed.In addition, the sealant was observed exposed.The sealant sleeve was inspected under the vision system to obtain a magnified image and a kinked condition was found with the outer sleeve.The reported event of ¿balloon-balloon loss of pressure¿ was confirmed through analysis of the returned device.Additionally, a condition was noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ as an exposure of the sealant was observed due to the kinked condition of the sealant sleeves noted.However, the exact cause of the pin hole found in the balloon and the condition of the exposed sealant 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, prepping/handling factors, access site vessel characteristics (although not reported) and/or concomitant device factors most likely contributed to the reported event 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.Additionally, these factors could also contribute to the kinked 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 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.If the outer sleeve is damaged/kinked during prepping phase and/or insertion into the sheath, that could cause the sealant to be exposed/swollen prematurely.However, as this condition was not reported by the customer, it is unknown if this received condition occurred due to manipulations after 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.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.

Event Description

As reported, the balloon of a 6/7f mynx control vascular closure device (vcd) ruptured.There was no reported patient injury.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.Addendum: product evaluation revealed the sealant remained in the manufacturing position swelled by the blood saturation and exposed.

Manufacturer Narrative

Device was returned to a cordis distribution center and was not delivered to the decontamination lab until later; therefore, the date of receipt that was used was the date it arrived to a cordis facility.September 21st, 2023.

• 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: 17885552
• MDR Text Key: 325079792
• Report Number: 3004939290-2023-03405
• 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,Followup,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• 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: F2322102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2023
• 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: UNKNOWN.