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 07/11/2023

Event Type  malfunction  

Event Description

As reported, 6f/7f mynx control vascular closure device could not enter the sheath because the catheter tip (the sealant sleeve) part was bent.Therefore, the product wasn¿t available and manual compression was performed for twenty minutes and recovered.There was no reported patient injury.The device was 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.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 tip was the sealant sleeve.It was bent.A 6f non cordis sheath was used.The access site had no tortuosity.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.The device will be returned for evaluation.Addendum: product evaluation demonstrates that the sealant was found exposed from the sealant sleeves.

Manufacturer Narrative

As reported, 6f/7f mynx control vascular closure device could not enter the sheath because the catheter tip (the sealant sleeve) part was bent.Therefore, the product wasn¿t available and manual compression was performed for twenty minutes and recovered.There was no reported patient injury.The device was 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.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 tip was the sealant sleeve, and it was bent.A 6f non cordis sheath was used.The access site had no tortuosity.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.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.The syringe was not received for evaluation, and the stopcock was found opened.The sealant was found exposed from the sealant sleeves as it was observed to have been severely kinked/bent as received.In addition, the procedural sheath was not returned with the device.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 with 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.The returned device performed as intended per the mynx control ifu.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 exposed from the sealant sleeves as they were observed to have been severely kinked/bent as received.The reported event of ¿mynx control system-kinked/bent¿ was confirmed through analysis of the returned device.Additionally, a condition was noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ due to the exposed sealant from the severely kinked/bent 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 incorrect insertion angle), 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.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 noted could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.

Manufacturer Narrative

Section g3 was corrected.

• 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 ; 14021 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 18226028
• MDR Text Key: 329192323
• Report Number: 3004939290-2023-03507
• 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: 11/29/2023

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 Model Number: N/A
• Device Catalogue Number: MX6760E
• Device Lot Number: F2308005
• 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: 11/17/2023
• Initial Date FDA Received: 11/29/2023
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 11/29/2023
• 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: 6F TERUMO SHEATH.