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 12/04/2023

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 5f mynx control vascular closure device (vcd) ruptured during the procedure.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use.The vcd will be returned for further analysis and evaluation.

Event Description

As reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured during the procedure.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use.The device was used in a diagnostic procedure using a retrograde approach.The deployer was certified in the use of the mynx device.The vcd was used with a 5f non-cordis sheath.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 5mm in diameter.There was little vessel tortuosity.There was no presence of pvd or calcium in the vicinity of the puncture site.Hemostasis was achieved by manual compression for less than 30 minutes.The balloon lost pressure inside the patient.There was no prior pta, stent, or vascular graft in the common femoral artery or vein.The vcd will be returned for further analysis and evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, d2, g1, g3, g6, h1, h2, h3 and h6.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 balloon of a 5f mynx control vascular closure device (vcd) ruptured during the procedure.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use.The device was used in a diagnostic procedure using a retrograde approach.The deployer was certified in the use of the mynx device.The vcd was used with a 5f non-cordis sheath.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 5mm in diameter.There was little vessel tortuosity.There was no presence of pvd or calcium in the vicinity of the puncture site.Hemostasis was achieved by manual compression for less than 30 minutes.The balloon lost pressure inside the patient.There was no prior pta, stent, or vascular graft in the common femoral artery or vein.The vcd will be returned for further analysis and evaluation.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: b5, d2, g1, g3, g6, h1, h2, h3 and h6.As reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured during the procedure.There was no reported patient injury.The device was stored and prepared in accordance with the instructions for use.The device was used in a diagnostic procedure using a retrograde approach.The deployer was certified in the use of the mynx device.The vcd was used with a 5f non-cordis sheath.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 5mm in diameter.There was little vessel tortuosity.There was no presence of peripheral vascular disease (pvd) or calcium in the vicinity of the puncture site.Hemostasis was achieved by manual compression for less than 30 minutes.The balloon lost pressure inside the patient.There was no prior percutaneous transluminal angioplasty (pta), stent, or vascular graft in the common femoral artery or vein.A non-sterile ¿mynx control vcd 5f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that button 1 and button 2 were not depressed.The syringe was received separated from the device, and an unknown procedural sheath was locked onto the sheath catch.The stopcock was observed opened, and the balloon was found fully deflated.In addition, the sealant was found to be exposed from the sealant sleeves, which were observed to have been severely kinked/bent outward as received; however, no cracks were observed on it.Per functional analysis, a simulated deployment test was performed on the returned device per the mynx control instructions for use (ifu), step 2: deploy sealant.Button 1 was able to be depressed to deploy the sealant with no resistance felt.No issues were noted with respect to button 1 deployment during the device failure investigation.The returned device performed as intended per the mynx control ifu.Button #2 was able to be fully depressed, and no issues were noted with respect to button 2.Per microscopic analysis, visual inspection at high magnification revealed a longitudinal tear in the balloon of the return device.In addition, the sealant was found exposed from the sealant sleeves due to the observed severely kinked/bent outward condition with no cracks on it.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 severely kinked condition of the sealant sleeves noted.However, the exact cause of the longitudinal tear 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 (although reported to have no presence of pvd/calcium in the vicinity of the puncture site) and/or concomitant device factors 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: 18376213
• MDR Text Key: 331132667
• Report Number: 3004939290-2023-03548
• 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,Followup
• Report Date: 03/04/2024

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: F2316601
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/21/2023
• Supplement Dates Manufacturer Received: 12/22/2023; 02/19/2024
• Supplement Dates FDA Received: 01/16/2024; 03/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2023
• 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.; NA.