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

Model Number N/A

Device Problem Premature Activation (1484)

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

Event Date 09/26/2023

Event Type  malfunction  

Manufacturer Narrative

This device has been analyzed but the final, approved draft of the engineering report and its conclusion is not yet available due to need for additional testing.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, when a 5f mynx control vascular closure device entered a 5f non cordis sheath, the operator felt a strong sense of resistance, so the device was removed.It is understood that sealant protection cracked while passing through the sheath, so the sealant first met blood and reacted.Therefore, the product wasn¿t available and manual compression was performed for twenty minutes and patient recovered.There was no reported patient injury.The device was stored, prepped, and used in accordance with the instructions for use (ifu).The device was used in a percutaneous transluminal angioplasty (pta) using a retrograde approach.Button one was never depressed and no issue with the button.There were no visible signs of device/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/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.Adequate flush was used/maintained.The device will be returned for evaluation.Addendum: product analysis demonstrates that the sealant remained in the manufacturing position and was prematurely exposed.

Manufacturer Narrative

Complaint conclusion: as reported, when a 5f mynx control vascular closure device (vcd) entered a 5f non-cordis sheath, the operator felt a strong sense of resistance, so the device was removed.It is understood that sealant protection cracked while passing through the sheath, so the sealant first met blood and reacted.Therefore, the product wasn¿t available and manual compression was performed for twenty minutes and the patient recovered.There was no reported patient injury.The device was stored, prepped, and used in accordance with the instructions for use (ifu).The device was used in a percutaneous transluminal angioplasty (pta) using a retrograde approach.Button one was never depressed and there was no issue with the button.There were no visible signs of device/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/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.Adequate flush was used/maintained.A non-sterile ¿mynx control vcd 5f (ce mark)¿ was returned for investigation.Per visual analysis, the unit was thoroughly inspected observing that button 1 and button 2 were not depressed.The syringe was not returned.The stopcock was set in the open position.The sealant remained in its manufactured position and was prematurely exposed.No damages in the atraumatic wire were observed.In addition, the sealant sleeves were found damaged as a kink was found.No other outstanding details were noticed.Per function analysis, a simulated insertion/withdrawal test into a previously flushed lab sample catheter sheath introducer (csi) was intended to be performed as is indicated in the ifu.However, it was not possible due to the damage on the sealant sleeves.Per microscopic analysis, the sealant sleeve was inspected under the vision system to obtain a magnified image and a kinked condition was found with the outer sleeve.The reported event of ¿sealant sleeves (cartridge assembly)-cracked¿ was not confirmed through analysis of the returned device; however, a 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 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), 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): 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 33014 ; 7863138372
• MDR Report Key: 18639995
• MDR Text Key: 334549986
• Report Number: 3004939290-2024-00059
• 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
• Report Date: 02/13/2024

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 Model Number: N/A
• Device Catalogue Number: MX5060E
• Device Lot Number: F2320006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/11/2024
• Initial Date FDA Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/19/2023
• 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