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

Catalog Number MX6760

Device Problem Premature Activation (1484)

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

Event Date 09/07/2023

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.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, the tip of a 6f/7f mynx control vascular closure device (vcd) where the sealant is housed was frayed/falling apart.A second 6f/7f mynx control vcd was opened and the same issue at the tip was noted.A third mynx was opened and that was good and deployed successfully without issues.There was no reported patient injury.The user tested and prepped the balloons in the usual fashion without issues.The issue was noted as he was about to introduce the devices into the sheath.Neither of the faulty devices were introduced into the patient body.The device was stored as per the instructions for use (ifu).There was no damage to the packaging, nor was it difficult to remove from the packaging.The devices will be returned for evaluation.Addendum: product analysis of both devices demonstrates that the sealant was observed to be partially swollen resulting in a minor exposure.

Manufacturer Narrative

This report is related to report #3004939290-2023-03538.Complaint conclusion: as reported, the tip of a 6f/7f mynx control vascular closure device (vcd), where the sealant is housed, was frayed/falling apart.A second 6f/7f mynx control vcd was opened and the same issue at the tip was noted.A third mynx was opened and that was good and deployed successfully without issues.There was no reported patient injury.The user tested and prepped the balloons in the usual fashion without issues.The issue was noted as the user was about to introduce the devices into the sheath.Neither of the faulty devices were introduced into the patient¿s body.The device was stored as per the instructions for use (ifu).There was no damage to the packaging, nor was it difficult to remove from the packaging.(b)(4).: a non-sterile mynx control vascular closure device 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 sealant remained in its manufactured position fully covered by the sealant outer sleeve assembly, which showed evidence traces of the frayed/split/torn condition reported as received.No other damages/anomalies were observed on the returned device during the unaided eye visual inspection.The syringe and procedural sheath were not returned with the device.Per dimensional analysis, the slit length was verified and noted to be within specification.A cordis lab¿s applicable csi was used for the functional insertion/ withdrawal test where no friction nor resistance was perceived during this analysis.Per microscopic analysis, visual inspection at high magnification showed that the sealant outer sleeve assembly showed a minor sealant sleeves aperture during the magnified inspection where the sealant was observed to be partially swelled, resulting in a minor exposure.This condition could be related to the reported event.A functional deployment mechanism test was executed due to the sealant¿s partial exposure observed during the microscopic analysis.During this test, the deployment of the sealant and complete retraction of the balloon was achieved after both buttons were fully depressed.The reported events of ¿sealant sleeves (cartridge assembly)-frayed/split/torn¿ were confirmed through microscopic analysis of the returned devices since there was an aperture in the sleeves that could be considered wider than expected from manufactured initial conditions.Additionally, a condition was noted in the returned devices of ¿mynx control system-deployment difficulty-premature¿ due to the exposed sealant from the damaged 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 damaged conditions of the sealant sleeves, and the subsequent premature exposure of the sealants.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/shredded 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 analyses, nor the information available for review suggest that the failures could be related to the design or manufacturing process of the units.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: 18324393
• MDR Text Key: 330481280
• Report Number: 3004939290-2023-03531
• Device Sequence Number: 1
• Product Code: MGB
• UDI-Device Identifier: 10862028000410
• UDI-Public: 10862028000410
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/18/2023

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: MX6760
• Device Lot Number: F2317203
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2023
• Initial Date FDA Received: 12/14/2023
• Supplement Dates Manufacturer Received: 12/14/2023
• Supplement Dates FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2023
• 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