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)

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

Event Date 02/19/2024

Event Type  malfunction  

Event Description

As reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured during the procedure.Hemostasis was achieved by manual compression for less than thirty minutes.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use (ifu).The femoral artery¿s suitability was verified on angiography including the insertion angle (30-45 degrees) of the 5f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was mild vessel tortuosity.There was mild presence of calcium in the vicinity of the puncture site.There was no prior pta, stent, or vascular graft in the common femoral artery.The mynx vcd was used in a diagnostic procedure with a retrograde approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.

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

Event Description

As reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured during the procedure.Hemostasis was achieved by manual compression for less than thirty minutes.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use (ifu).The femoral artery¿s suitability was verified on angiography including the insertion angle (30-45 degrees) of the 5f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was mild vessel tortuosity.There was mild presence of calcium in the vicinity of the puncture site.There was no prior pta, stent, or vascular graft in the common femoral artery.The mynx vcd was used in a diagnostic procedure with a retrograde approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.Addendum: per product evaluation the sealant of a 5f mynx control vascular closure device (vcd) remained in the manufacturing position exposed due to the blood saturation and due to the sealant sleeves present a kinked condition.

Manufacturer Narrative

Complaint conclusion: as reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured during the procedure.Hemostasis was achieved by manual compression for less than thirty minutes.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use (ifu).The femoral artery¿s suitability was verified on angiography including the insertion angle (30-45 degrees) of the 5f non-cordis vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was mild vessel tortuosity.There was mild presence of calcium in the vicinity of the puncture site.There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery.The mynx vcd was used in a diagnostic procedure with a retrograde approach.The deployer¿s mynx certified.Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.A non-sterile ¿mynx control vcd, 5f (ce mark)¿ was returned for investigation.Per visual analysis, the unit was thoroughly inspected, observing that both button 1 and button 2 were not depressed.Neither the syringe, nor the procedural sheath were returned for analysis.The stopcock was set in the closed position.The sealant remained in its manufactured position, exposed due to blood saturation.The sealant sleeves presented a kinked/bent condition.The atraumatic tip did not present any damages or anomalies.No other outstanding details were noticed.Per dimensional analysis, the catheter working length was measured, and result was verified to be within specification.However, the slit length on the outer sleeve was not verified due to the kinked condition of the sealant sleeve assembly.Per functional analysis, an inflation/deflation test was performed by injecting water into the returned device according to the ifu.A leaking condition was observed on the balloon.Per microscopic analysis, the balloon was inspected using a vision system to obtain a magnified image, and one pin hole was observed.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 and blood saturation.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 information available for review and product analysis, it is difficult to determine what factors may have contributed to the issues noted.However, access site vessel characteristics (there was mild vessel tortuosity and mild presence of calcium in the vicinity of the puncture site) and/or concomitant device factors (which was not returned) most likely contributed to the reported event since 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 ifu instructs the user to discard the device if the balloon does not maintain pressure.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: 18921910
• MDR Text Key: 337876349
• Report Number: 3004939290-2024-00126
• 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: 05/15/2024

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: MX5060E
• Device Lot Number: F2324002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/29/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/18/2024
• Supplement Dates Manufacturer Received: 05/08/2024
• Supplement Dates FDA Received: 05/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2023
• 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: 5F TERUMO SHEATH.