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

Catalog Number MX5060E

Device Problems Entrapment of Device (1212); Premature Activation (1484); Difficult to Remove (1528); Mechanical Jam (2983)

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

Event Date 07/20/2023

Event Type  malfunction  

Event Description

As reported, a 5f mynx control vascular closure device (vcd) could not enter the sheath because the sealant sleeves were compressed.Manual compression was performed for 20 minutes for hemostasis.There was no reported patient injury.The vcd was prepared and used in accordance with the instructions for use (ifu).The vcd was used in a trans-femoral cerebral angiogram using a retrograde approach.There were no visible signs of device or package damage prior to use.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.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 5mm in diameter.The puncture site did not have visible calcium or plaque.There was no stent near the puncture site.The vessel did not have stenosis >50% at the puncture site.The target femoral site was not previously closed with any closure less than 30 days prior to this procedure.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to use mynx control.The vcd was used with a 5f non- cordis sheath.There was little vessel tortuosity.The sheath was not kinked or bent upon removal.There was no visible bend or damage noted on the distal end of the balloon shaft after removal.There was no excess force applied during insertion.The device is being returned for evaluation.Addendum: product evaluation shows the sealant was found fully exposed from the sealant sleeves assembly.Additionally, it was noted that there was crystallized residual fluid in the balloon and after functional testing, button #2 was not able to be fully depressed and the balloon was not completely retracted into the tamp tube.

Manufacturer Narrative

As reported, a 5f mynx control vascular closure device (vcd) could not enter the sheath because the sealant sleeves were compressed.Manual compression was performed for 20 minutes for hemostasis.There was no reported patient injury.The vcd was prepared and used in accordance with the instructions for use (ifu).The vcd was used in a trans-femoral cerebral angiogram using a retrograde approach.There were no visible signs of device or package damage prior to use.The physician achieved certification on the use of mynx and has used the device several times prior to this procedure.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 5mm in diameter.The puncture site did not have visible calcium or plaque.There was no stent near the puncture site.The vessel did not have stenosis >50% at the puncture site.The target femoral site was not previously closed with any closure less than 30 days prior to this procedure.There was no evidence of pre-existing hematoma, arteriovenous fistula, or pseudoaneurysm at the access site prior to use mynx control.The vcd was used with a 5f non- cordis sheath.There was little vessel tortuosity.The sheath was not kinked or bent upon removal.There was no visible bend or damage noted on the distal end of the balloon shaft after removal.There was no excess force applied during insertion.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 with the stopcock opened, and the syringe was received separated from the device.The sealant was found fully exposed from the sealant sleeves assembly, which was observed to have been severely kinked/bent outward as received.In addition, the procedural sheath was not received for evaluation and the balloon was observed fully deflated and it was noted that there was crystallized residual fluid in the balloon.Dimensional analysis could not be performed on the returned device due to the severely kinked/bent sealant sleeve assembly condition.Per functional analysis, 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 unable to be fully depressed as it was noted that there was crystallized residual fluid in the balloon which may have contributed to the button 2 depression issue.Per microscopic analysis, visual inspection at high magnification showed that the sealant was found fully exposed from the sealant sleeves assembly due to the severely kinked/bent outward condition as received.In addition, it was noted that there was crystallized residual fluid in the balloon, and after the functional test, button #2 was not able to be fully depressed and the balloon was not completely retracted into the tamp tube.The reported event of ¿sealant sleeves (cartridge assembly)-compressed/crushed¿ was not confirmed through analysis of the returned device; however, the sealant sleeves were found to be severely kinked/bent.Additionally, conditions were noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ due to the exposed sealant from the severely kinked/bent sleeves, and ¿button #2-frozen/locked¿ and ¿balloon-retraction jam¿ due to the issue experienced during functional analysis.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 by the customer.However, procedural/handling factors (although it was reported that there was no excessive force applied) and/or the condition of the sheath (although not returned) possibly 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 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, 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.Regarding the issues experienced during functional analysis of button 2, the inability to fully retract the balloon into the tamp tube and fully depress button 2 was likely due to the crystallized solution with the deflated balloon.However, this condition was unlikely to have occurred during use of the device by the customer as the saline solution would not likely have been crystallized when attempting to use this mechanism.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.¿ also included in the ifu, step 3: remove device states to ¿retract the syringe plunger to lock position.Apply light fingertip compression proximal to the insertion site and then lightly grasp the device at skin with thumb and forefinger and realign with the tissue tract.Open the stopcock to deflate the balloon.To ensure complete balloon deflation, wait until air bubbles and fluid have stopped moving through the inflation tubing.Pick up the device handle and realign with the tissue tract.Depress button #2 to pull the deflated balloon into the device.¿ 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: 18245415
• MDR Text Key: 330387090
• Report Number: 3004939290-2023-03511
• 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: 12/01/2023

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: 08/31/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/14/2023
• Initial Date FDA Received: 12/01/2023
• 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
• Treatment: 5F TERUMO SHEATH.