MAUDE Adverse Event Report: CORDIS 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, the sealant sleeve of a 5f mynx vascular closure device (vcd) was split; therefore, the device could not enter a 5f non-cordis sheath.Hemostasis was achieved by holding manual pressure for twenty (20 minutes).There was no reported patient injury.The damage to the sealant sleeve was noted after removal.The physician was mynx certified.The device was stored according to the instructions for use (ifu).The storage of the device did not exceed 25 °c.There were no anomalies noted prior to use.The mynx device was prepped according to the ifu, and no difficulty was noted.The mynx device was not purged of air during prep.A 5f non-cordis sheath was used during the procedure.No unusual force was applied when the sheath was retracted.There were no kinks on the sheath after removal.There was no damage to the button.The button was not depressed at all.The tension indicator was not aligned with the markers on the handle halves before attempting to deploy.The stick location was above the femoral head.The femoral artery 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.There was no presence of pvd/calcium in the vicinity of the puncture site.The vessel was reported to have moderate tortuosity.The device was returned for evaluation.Product evaluation revealed that the sealant sleeves were not fully covering the sealant and noted swollen from exposure to blood; additionally, the balloon was observed deflated with crystallized residues.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the sealant sleeve of a 5f mynx control vascular closure device (vcd) was split; therefore, the device could not enter a 5f non-cordis sheath.Hemostasis was achieved by holding manual pressure for twenty (20 minutes).There was no reported patient injury.The damage to the sealant sleeve was noted after removal.The physician was mynx certified.The device was stored according to the instructions for use (ifu).The storage of the device did not exceed 25 °c.There were no anomalies noted prior to use.The mynx device was prepped according to the instructions for use (ifu), and no difficulty was noted.The mynx device was not purged of air during prep.A 5f non-cordis sheath was used during the procedure.No unusual force was applied when the sheath was retracted.There were no kinks on the sheath after removal.There was no damage to the button.The button was not depressed at all.The tension indicator was not aligned with the markers on the handle halves before attempting to deploy.The stick location was above the femoral head.The femoral artery 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.There was no presence of peripheral vascular disease (pvd)/calcium in the vicinity of the puncture site.The vessel was reported to 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 button 1 and button 2 were not depressed.The syringe and the procedural sheath were not returned, and the stopcock was observed opened.The sealant sleeve assembly was observed to have been severely kinked/bent as received.Additionally, the sealant sleeves were not fully covering the sealant, and it was noted to be swelled from exposure to blood.The balloon was observed deflated, and it was noted that there were crystallized residuals in the balloon.A dimensional test was not performed on the returned device due to the damages to the sealant outer sleeve assembly as received.Per functional analysis, an insertion/withdrawal test could not be performed on the returned device due the severely kinked/bent sealant sleeve assembly condition and the swollen condition of the blood-exposed sealant.In addition, per sealant condition, a simulated deployment test was performed on the returned device per the mynx control ifu.Some resistance was felt when attempting to depress button #1 as received; however, button 1 was able to be depressed to deploy the sealant.No other issues were noted with respect to button 1 deployment during the device failure investigation.Button #2 was not able to be fully depressed.Since there were crystallized residuals inside of the balloon, this may have contributed to the button #2 inability to be fully depressed.Per microscopic analysis, visual inspection at high magnification revealed that the sealant sleeve assembly was observed to have been severely kinked/bent as received.Additionally, the sealant sleeves were not fully covering the sealant, and it was noted swelled from exposure to blood.The balloon was observed deflated and it was noted that there were crystallized residuals.The reported event of ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ was not confirmed through analysis of the returned device; however, a severely kinked condition of the sleeves was noted.The reported event of ¿mynx control system-impeded¿ was confirmed since the device could not be inserted during an insertion/withdrawal test due to the kinked/bent sleeves.Additionally, a condition was noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ due to the exposed sealant from the kinked 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, 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.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): CORDIS SANTA CLARA; 5452 betsy ross drive; santa clara, california 95054
• Manufacturer (Section G): CORDIS US CORP.; 14201 nw 60th avenue; miami lakes, florida 33014
• Manufacturer Contact: karla castro ; 5452 betsy ross drive; santa clara, california 95054 ; 7863138372
• MDR Report Key: 18324125
• MDR Text Key: 330479041
• Report Number: 3004939290-2023-03530
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/29/2023

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: F2313204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 12/20/2023
• Supplement Dates FDA Received: 12/29/2023
• Date Device Manufactured: 05/15/2023
• 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