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 09/11/2023

Event Type  malfunction  

Event Description

As reported, when a 5f mynx control vascular closure device entered the 5f non cordis sheath, the operator felt a strong sense of resistance, so removed the product.The sealant protection cracked while passing through the sheath.The sealant first met the blood and reacted.Therefore, the product wasn¿t available and manual compression was performed for twenty minutes and recovered.The device was used and prepped as per the instructions for use (ifu).The mynx vcd used in coronary angiography (cag) using a retrograde approach.A non cordis sheath was used.The product was stored normally based on ifu.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 mild tortuosity of access site vessel.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 sheath was not kinked/bent upon removal.There was no visible bent/damage in distal end of the balloon shaft after removal.The device will be returned for evaluation.Addendum: product analysis demonstrates that the sealant was found exposed from the sealant sleeves.

Manufacturer Narrative

As reported, when a 5f mynx control vascular closure device entered a 5f non-cordis sheath, the operator felt a strong sense of resistance, then removed the product.The sealant protection cracked while passing through the sheath.The sealant first met the blood and reacted.Therefore, the product wasn¿t available and manual compression was performed for twenty minutes and recovered.The device was used and prepped as per the instructions for use (ifu).The mynx vcd used in coronary angiography (cag) using a retrograde approach.A non-cordis sheath was used.The product was stored normally based on ifu.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 mild tortuosity of access site vessel.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 sheath was not kinked/bent upon removal.There was no visible bent/damage in distal end of the balloon shaft after removal.A non-sterile ¿mynx control vcd 5f¿ was returned for evaluation.Per visual inspection, button 1 and button 2 were not depressed.The balloon was found fully deflated.The stopcock was observed open.The sealant sleeves were severely kinked/bent outward, which led to the exposure of the sealant.No cracks were observed on the sealant sleeve.No damages were found on the distal tip of the atraumatic wire.The syringe and procedure sheath were not received for evaluation.An insertion/withdrawal test could not be performed due to the severely kinked/bent sealant sleeves.A simulated deployment test was performed and button 1 was depressed to deploy the sealant with no resistance felt.No issues were noted with respect to button 1.Button #2 was able to be fully depressed with no issues noted.Visual inspection at high magnification showed the sealant exposed from the sealant sleeves.This was due the kinked/bent condition of the sealant sleeves.No cracks were observed on the sealant sleeves under high magnification.The reported, ¿sealant sleeves (cartridge assembly) ~ cracked¿ was not confirmed.This condition was not observed however, the sealant sleeves were found bent outward.The reported, ¿mynx control system ~ impeded¿ could not be confirmed because an insertion/withdrawal test could not be performed due the condition of the sealant sleeves.The reported, ¿mynx control system-deployment difficulty-premature¿ was confirmed.The exact cause determined from the information provided however, it is likely due to the bent sleeves exposing the sealant.Procedural/handling factors, which caused the strong resistance on insertion, likely contributed to the kinked condition and the subsequent impedance experienced by the customer.It should be noted that the mynx control device is manufactured with the outer sealant sleeve assembly at the distal end of the catheter cartridge tubing.The outer sealant sleeve assembly is assembled with 2 side slit overlapping sleeves.The slits are designed to decrease unsheathing force and increase deployment reliability.The sealant is placed right under the outer sealant sleeve assembly and is protected from being exposed prematurely.If the sealant sleeve is damaged/shredded during handling or device insertion into the sheath, that could cause the sealant to be exposed prematurely and obstruct the device path and prevent the device from being inserted into the procedural sheath.As warned in the instructions for use (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.¿ the product analysis does not suggest that the reported 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 ; 14021 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 18283465
• MDR Text Key: 329948885
• Report Number: 3004939290-2023-03520
• 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: 12/07/2023

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: MX5060E
• Device Lot Number: F2313501
• 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: 11/21/2023
• Initial Date FDA Received: 12/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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 TERUMO SHEATH