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 08/18/2023

Event Type  malfunction  

Event Description

As reported, a 5f mynx control vascular closure device (vcd) ¿did not contain the sealant¿ as there was no sealant present in the mynx control vcd.It was also reported that the vascular puncture was ¿above¿ the femoral head; however, hemostasis was able to be achieved via 20 minutes of manual compression.There were no reported injuries to the patient.The device was stored and prepped according to the instructions for use (ifu); however, the mynx vcd was not purged of air during preparation.The storage of the device did not exceed 25 degrees celsius and there were no anomalies noted prior to using the mynx control vcd.A 5f non-cordis catheter sheath introducer (csi) was used during the procedure and there were no observed kinks in the csi after its removal.Excess force was not used during the retraction of the device.It was reported the button was not depressed.The access vessel diameter was verified to be greater than or equal to 5mm.The vessel did have moderate tortuosity.The device will be returned for evaluation.Addendum: product evaluation revealed that the sealant was returned but was prematurely exposed.

Manufacturer Narrative

This device has been analyzed but the final, approved draft of the engineering report and its conclusion 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.

Manufacturer Narrative

Complaint conclusion: as reported, a 5f mynx control vascular closure device (vcd) ¿did not contain the sealant¿ as there was no sealant present in the mynx control vcd.It was also reported that the vascular puncture was ¿above¿ the femoral head; however, hemostasis was able to be achieved via 20 minutes of manual compression.There were no reported injuries to the patient.The device was stored and prepped according to the instructions for use (ifu); however, the mynx vcd was not purged of air during preparation.The storage of the device did not exceed 25 degrees celsius and there were no anomalies noted prior to using the mynx control vcd.A 5f non-cordis catheter sheath introducer (csi) was used during the procedure and there were no observed kinks in the csi after its removal.Excess force was not used during the retraction of the device.It was reported the button was not depressed.The access vessel diameter was verified to be greater than or equal to 5mm.The vessel did have moderate tortuosity.A non-sterile ¿mynx control vcd 5f¿ 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, and the stopcock was observed opened.The syringe was received connected to the device and the procedural sheath was not received for evaluation.The balloon was found fully deflated.The sealant was found exposed to blood and partially 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 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 that the sealant was found partially exposed from the sealant sleeves and exposed to blood due to the severely kinked/bent outward sealant sleeves as received with no cracks observed on it.The reported event of ¿sealant-missing component¿ was not confirmed through analysis of the returned device since the device contained a sealant.However, a condition was noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ due to the partially exposed sealant from severely kinked/bent sealant sleeves.The exact cause of the observed condition 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 excessive force during insertion as there was moderate tortuosity with the access vessel), 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, california 95054
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60 avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, california 95054 ; 7863138372
• MDR Report Key: 18419649
• MDR Text Key: 331716158
• Report Number: 3004939290-2023-03556
• 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
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

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 Catalogue Number: MX5060E
• Device Lot Number: F2313702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 12/29/2023
• Supplement Dates FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2023
• 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 NON CORDIS SHEATH