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 01/18/2024

Event Type  malfunction  

Event Description

As reported, the sealant sleeves of a 6/7f mynx control vascular closure device (vcd) split upon entrance into the sheath.There was no reported patient injury.The customer has been made aware of this design and claims to have inserted the device properly.The device was a mynx control.The split was on the sealant sleeves of the device.The device was stored and prepped per the instructions for use (ifu).The device was used in an interventional procedure using a retrograde approach.The user was certified in the use of the mynx device.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.Hemostasis was achieved with another mynx device.The device is being returned for evaluation.Addendum: product evalaution shows the sealant was exposed from the sealant sleeves.

Manufacturer Narrative

As reported, the sealant sleeves of a 6f/7f mynx control vascular closure device (vcd) split upon entrance into the sheath.There was no reported patient injury.The customer has been made aware of this design and claims to have inserted the device properly.The device was a mynx control.The split was on the sealant sleeves of the device.The device was stored and prepped per the instructions for use (ifu).The device was used in an interventional procedure using a retrograde approach.The user was certified in the use of the mynx device.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.Hemostasis was achieved with another mynx device.A non-sterile ¿mynx control vcd 6f-7f¿ involved in the reported complaint was returned for investigation.Visual inspection of the received device showed that both button 1 and button 2 were not depressed.The procedural sheath and the syringe were not returned for evaluation, and the stopcock was observed closed.In addition, the balloon was found fully deflated.The sealant was found exposed from the sealant sleeves and exposed to blood.The sealant sleeves were observed to have been severely kinked/bent.The device was inspected for damages/anomalies that may have contributed to the reported failure and no frayed/split/torn conditions were observed to the returned device.A dimensional test was not performed on the returned device due to the kinked/bent condition observed to the sealant outer sleeve assembly.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.Button #2 was able to be fully depressed, and no issues were noted with respect to button 2.The returned device performed as intended per the mynx control ifu.Per microscopic analysis, visual inspection at high magnification revealed that the sealant was found exposed from the sealant sleeves and exposed to blood.The sealant sleeves were observed to have been severely kinked/bent, however, no frayed/split/torn conditions were observed to the device.The reported event of ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ was not confirmed through analysis of the returned device; however, a severely kinked/bent condition of the sleeves was noted.Additionally, a condition was noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ due to the exposed sealant from the kinked sleeves.The exact cause of the observed conditions 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 issue experienced.However, procedural/handling factors (such as using excessive force during insertion into the sheath), and/or the condition of the sheath (although not returned) possibly contributed to the damaged 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 assembly is assembled with 2 side slit overlapping outer sleeves.The sealant is placed right under the outer sleeve assembly and is protected from exposing prematurely.The slits on the outer sleeve assembly are designed to decrease unsheathing force and increase deployment reliability.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, it could cause the sealant to be exposed/swollen prematurely and/or obstruct the device path and prevent the device from being inserted into the procedural sheath.As warned in the ifu, which is not intended as a mitigation, ¿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 ¿step 1: position balloon, insert the mynx control vcd into the procedural sheath through the sheath valve.Advance the catheter until the sheath catch nears the hub of the sheath.Rotate the sheath catch as needed to hook onto the side port of the procedural sheath.¿ neither the product analysis, nor the information available for review suggest that the failures 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: 19132615
• MDR Text Key: 341125409
• Report Number: 3004939290-2024-00191
• 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
• Report Date: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2024
• 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: F2334802
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2023
• 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 SHEATH