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

Catalog Number MX5060E

Device Problem Premature Activation (1484)

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

Event Date 07/25/2023

Event Type  malfunction  

Manufacturer Narrative

As reported, while advancing the device, the outer sleeve of a 5f mynx control vascular closure device (vcd) struck the edges of the sheath hub, causing it to split.As a result, it became difficult to fully insert the device.Another unknown mynx device was used to achieve hemostasis.There was no reported patient injury.The device was not inspected for damages when removed from the package.There were no damages noted to the packaging or device at that time.The device was prepped per instructions for use (ifu).The device was opened in a sterile field.The user is trained to the device.The device was stored and prepared according to the instructions for use (ifu).A non-sterile ¿mynx control vcd 5f¿ was returned for evaluation.Visual inspection showed button 1 and button 2 were not depressed.The syringe was not returned for evaluation.The stopcock was found open.In addition, an unknown procedure sheath was on the device and exposed to blood.The sealant was found partially exposed from the sealant sleeves due to a severely kinked/bent condition, however no cracks were observed.Dimensional analysis could not be performed due to the severely kinked/bent sealant sleeve assembly.A simulated deployment test was performed.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.Button #2 was able to be fully depressed, and no issues were noted with respect to button 2 either.Visual inspection at high magnification revealed the sealant was partially exposed from the sealant sleeves due to the severely kinked/bent condition.No cracks were observed.The reported ¿sealant sleeves-frayed/split/torn¿ was not confirmed however, the malfunction ¿mynx control system-deployment difficulty-premature¿, was confirmed due to the exposed sealant from the kinked/bent condition of the sealant sleeves.The exact cause of the observed condition could not be conclusively determined during the analysis.Based on the information available for review and product analysis, procedural/handling factors and/or the condition of the sheath may have contributed to the kinked/bent 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 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 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.¿ the product analysis does not suggest 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.

Event Description

As reported, while advancing the device, the outer sleeve of a 5f mynx control vascular closure device (vcd) struck the edges of the sheath hub, causing it to split.As a result, it became difficult to fully insert the device.Another unknown mynx device was used to achieve hemostasis.There was no reported patient injury.The device was not inspected for damages when removed from the package.There were no damages noted to the packaging or device at that time.The device was prepped per instructions for use (ifu).The device was opened in a sterile field.The user is trained to the device.The device was stored and prepared according to the instructions for use (ifu).Other procedural details were requested but are unknown, unavailable, not answered, or not applicable.The device will be returned for evaluation.Addendum: product evaluation shows that the sealant was found partially exposed from the sealant sleeves due it was observed to have been severely kinked/bent as received.

• 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: 18401217
• MDR Text Key: 331605356
• Report Number: 3004939290-2023-03553
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/27/2023

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: F2311702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2023
• 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