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

Catalog Number MX6760E

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

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

Event Date 09/07/2023

Event Type  malfunction  

Event Description

As reported, there was strong resistance felt when inserting a 6f/7f mynx control vascular closure device (vcd) in a non-cordis catheter sheath introducer (csi) and excess force was required.The resistance was felt towards the distal end of the csi.It was mentioned that the sealant protection had cracked while passing through the csi and the sealant was exposed to blood and reacted.There was no visible damage to the distal end of the balloon shaft after the removal of the vcd.As a result, the device was not used, and hemostasis was achieved via 20 minutes of manual compression.There were no reported injuries to the patient.This was during a percutaneous transluminal angioplasty (pta) procedure in which a retrograde approach was made.The device was stored and prepped per the instructions for use (ifu) and there were no visible signs of damage to the device or device packaging prior to use.The physician is mynx certified.The femoral artery¿s suitability was verified on angiography, including the csi insertion angle of 30 to 45 degrees, and a vessel diameter greater than 5mm in diameter.The puncture site did not have visible calcium/plaque; however, there was mild tortuosity at the access vessel.There was no stent near the puncture site, and the vessel did not have a stenosis greater than 50 percent.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 using the mynx control.There was no damage to the sheath observed after its removal and there was never an attempt to deploy the sealant.The device will be returned for evaluation.Addendum: pe completion revealed a balloon retraction jam, as well as a prematurely exposed sealant.

Manufacturer Narrative

Complaint conclusion: as reported, there was strong resistance felt when inserting a 6f/7f mynx control vascular closure device (vcd) in a non-cordis catheter sheath introducer (csi) and excess force was required.The resistance was felt towards the distal end of the csi.It was mentioned that the sealant protection had cracked while passing through the csi and the sealant was exposed to blood and reacted.There was no visible damage to the distal end of the balloon shaft after the removal of the vcd.As a result, the device was not used, and hemostasis was achieved via 20 minutes of manual compression.There were no reported injuries to the patient.This was during a percutaneous transluminal angioplasty (pta) procedure in which a retrograde approach was made.The device was stored and prepped per the instructions for use (ifu) and there were no visible signs of damage to the device or device packaging prior to use.The physician was mynx certified.The femoral artery¿s suitability was verified on angiography, including the csi insertion angle of 30 to 45 degrees, and a vessel diameter greater than 5mm in diameter.The puncture site did not have visible calcium/plaque; however, there was mild tortuosity at the access vessel.There was no stent near the puncture site, and the vessel did not have a stenosis greater than 50 percent.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 using the mynx control.There was no damage to the sheath observed after its removal and there was never an attempt to deploy the sealant.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 button 1 and button 2 were not depressed and the stopcock was observed opened.The syringe and procedural sheath were not received for evaluation.The balloon was found fully deflated; however, it was noted that there were crystallized residuals on it.Additionally, the sealant was found exposed from the sealant sleeves, which were observed to have been severely kinked/bent as received, however, no cracks were observed on it.No damages were found in the atraumatic wire distal tip.Per functional analysis, without the return of the procedure 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.However, an applicable lab sample csi was used to perform the insertion/withdrawal test with the returned product, and the device was able to be inserted/advanced through the csi without issue during the device failure investigation.The returned device performed as intended per the mynx control ifu.In addition, 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.Button #2 was not able to be fully depressed since it was noted that on the balloon had crystallized residuals, which may have contributed to the incomplete withdrawal of the balloon into the tube.Per microscopic analysis, visual inspection at high magnification showed that the balloon was found fully deflated; however, it was noted that there were crystallized residuals on it.Additionally, the sealant was found exposed from severely kinked/bent sealant sleeves with no cracks observed on it.After the functional test, the balloon was not completely withdrawn into the tube per the crystallized residuals on it.In addition, the internal mechanism was assembled correctly, and no anomalies were observed.The device was inspected for damages/anomalies that may have contributed to the reported failure.No damages/anomalies were observed on the returned device.The reported events of ¿sealant sleeves (cartridge assembly)-cracked¿ and ¿mynx control system-impeded¿ were not confirmed through analysis of the returned device since there were no cracks and the device passed the insertion/withdrawal test; however, a severely kinked condition of the sleeves was noted.Additionally, conditions were noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ due to the exposed sealant from the kinked sleeves, and ¿balloon-retraction jam¿ since the balloon could not be completely retracted due to the crystallized residuals on the balloon.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 excessive force during insertion as there was mild 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, the impedance 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 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.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 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: 18436981
• MDR Text Key: 331932309
• Report Number: 3004939290-2024-00008
• 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
• Type of Report: Initial
• 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: MX6760E
• Device Lot Number: F2308005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/19/2023
• Initial Date FDA Received: 01/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2023
• 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: TERUMO SHEATH; UNK VASCULAR SHEATH INTRODUCER