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

Model Number N/A

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

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

Event Date 08/15/2023

Event Type  malfunction  

Manufacturer Narrative

As reported, the balloon of a 6f/7f mynx control vascular closure device (vcd) did not want to inflate despite it being prepped as per the instructions for use (ifu).The mynx could not deploy.The sealant was not deployed at all.A second unit was opened and worked perfectly.There was no reported patient injury.The interventional peripheral procedure used an antegrade approach.The user was mynx certified.A 7f non-cordis sheath was used.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was moderate vessel tortuosity and moderate presence of peripheral vascular disease (pvd)/calcium in the vicinity of the puncture site.There were no kinks in the sheath after removal.There were no damages noted to the sealant sleeves after removal.The tension indicator was not aligned with the markers on the handle halves before attempting to deploy.The tension indicator did not display a ¿clock symbol¿ after button # 1 depression.A non-sterile ¿mynx control vcd, 6f/7f¿ was returned for investigation.Per visual analysis, the unit was thoroughly inspected, observing that both button 1 and button 2 were not depressed.The syringe was returned for analysis; however, the sheath was not returned.The stopcock was set in the open position.The sealant remained in the manufacturing position, swelled by the blood saturation and was prematurely 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 as indicated with in the 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 a pin hole was confirmed.The reported event of ¿balloon-inflation difficulty¿ was confirmed through analysis of the returned device due to a leak in the balloon that prevented inflation.Therefore, an additional condition of ¿balloon-balloon loss of pressure¿ was found due to the leak.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 condition of the sealant sleeves noted.However, the exact cause of the reported pin hole found in the balloon and the condition of the exposed sealant could not be conclusively determined during analysis.Based on the information available for review and product analysis, access site vessel characteristics (there was moderate vessel tortuosity and moderate presence of pvd/calcium in the vicinity of the puncture site) and/or concomitant device factors (although not returned) likely contributed to the issues found since this type of damage to the balloon can occur when the balloon comes into contact with calcification and/or other procedural devices.Additionally, these factors could also contribute to the premature exposure of the sealant from the sealant sleeves.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/shredded during prepping phase and/or insertion into 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, ¿the safety and effectiveness of the mynx control vcd have not been established in the following patient populations: patients with clinically significant peripheral vascular disease in the vicinity of the puncture.¿ also stated in the ifu during product preparation, ¿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.¿ additionally, users are instructed to discard the device if the balloon does not maintain pressure.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.¿ 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 6f/7f mynx control vascular closure device (vcd) did not want to inflate despite it being prepped as per the instructions for use (ifu).The mynx could not deploy.The sealant was not deployed at all.A second unit was opened and worked perfectly.There was no reported patient injury.The interventional peripheral procedure used an antegrade approach.The user is mynx certified.A 7f non cordis sheath was used.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was moderate vessel tortuosity and moderate presence of pvd / calcium in the vicinity of the puncture site.There were no kinks in the sheath after removal.There were no damages noted to the sealant sleeves after removal.The tension indicator was not aligned with the markers on the handle halves before attempting to deploy.The tension indicator did not display a ¿clock symbol¿ after button # 1 depression.The device will be returned for evaluation.Addendum: product analysis demonstrates a leak in the balloon and the sealant was prematurely exposed.

• 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 ; 14021 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 18141389
• MDR Text Key: 328183638
• Report Number: 3004939290-2023-03491
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• UDI-Public: 10862028000410
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2023
• 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: F2301202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/13/2023
• 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: COOK CHEQUE FLOW 7F SHEATH.; UNKNOWN SECOND DEVICE,
• Patient Sex: Male
• Patient Weight: 87 KG