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

Catalog Number MX6760E

Device Problem Premature Activation (1484)

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

Event Date 01/03/2024

Event Type  malfunction  

Event Description

As reported, there was resistance when inserting a 6/7f mynxcontrol vascular closure device (vcd) into an unknown sheath and it was not the "normal feeling".Another mynx device was used for hemostasis.There was no reported patient injury.The vcd was used in a diagnostic procedure.The deployer 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.There were no kinks in the sheath after removal.There was a visible bend/damage in distal end of the balloon shaft after removal.The device is being returned for evaluation.Addendum: picture and product analysis demonstrates that the sealant was found partially exposed from the sealant sleeves.

Manufacturer Narrative

As reported, there was resistance when inserting a 6f/7f mynx control vascular closure device (vcd) into an unknown sheath and it was not the "normal feeling".Another mynx device was used for hemostasis.There was no reported patient injury.The vcd was used in a diagnostic procedure.The deployer 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.There were no kinks in the sheath after removal.There was a visible bend/damage in distal end of the balloon shaft after removal.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 syringe and the procedural sheath were not received for evaluation and the stopcock was observed opened.In addition, the balloon was found fully deflated.Additionally, the sealant was found partially exposed from the sealant sleeves and swelled from exposure to blood.In addition, the sealant sleeves were observed kinked/bent as received; however, no cracks were observed on it.Per functional analysis, without the return of the involved procedural sheath, a physical evaluation to determine whether there was damage to the procedural sheath that could have contributed to the reported complaint could not be made.An applicable lab sample catheter sheath introducer (csi) was used to perform the insertion/withdrawal test on the returned product.Resistance was felt due to the damages of the sealant outer sleeve assembly; however, once it passed the csi¿s valve, the device was able to be advanced through the csi as intended per the mynx control instructions for use (ifu).A simulated deployment test was performed on the returned device per the mynx control ifu.Button 1 was able to be fully depressed and locked in place with some resistance felt.It was revealed that the sealant was exposed to blood which caused the resistance felt when attempting to depress button 1.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 showed that the sealant was found partially exposed from the sealant sleeves and swelled from exposure to blood.In addition, the sealant sleeves were observed kinked/bent as received; however, no cracks were observed on it.The reported events of ¿mynx control system-resistance/friction with csi¿ and ¿mynx control system-impeded¿ were confirmed through analysis of the returned device since resistance was experienced during the insertion/withdrawal test and a kinked/bent condition of the sealant sleeves was noted during visual analysis.Additionally, a condition was noted of ¿mynx control system-deployment difficulty-premature¿ due to the partially exposed sealant from the kinked/bent sealant 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 issues experienced.However, procedural/handling factors (such as excessive force applied during insertion into the sheath), and/or the condition of the sheath (which was not returned) possibly contributed to the kinked/bent condition of the sealant sleeves, the resistance experienced during insertion, 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 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, 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.¿ neither the product analysis, nor the information available for review suggest that the reported 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: 19040965
• MDR Text Key: 339374287
• Report Number: 3004939290-2024-00159
• Device Sequence Number: 1
• Product Code: MGB
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 04/04/2024

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: MX6760E
• Device Lot Number: F2319305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2024
• Initial Date FDA Received: 04/04/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• 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: .UNKNOWN
• Patient Ethnicity: Non Hispanic
• Patient Race: White