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 09/01/2023

Event Type  malfunction  

Event Description

As reported, the user tried to "enter" and use a 6f/7f mynx control vascular closure device (vcd) to stop bleeding, but it failed because the white tube tip was damaged and did not enter the unknown sheath.There was no reported patient injury.The device was used after a percutaneous coronary intervention (pci).The device will be returned for evaluation.Addendum: product analysis demonstrates that the sealant showed a partial portion exposed.

Manufacturer Narrative

This device is available for analysis but the engineering report 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.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h2, h3, h6, and h10.Complaint conclusion: as reported, the user tried to "enter" and use a 6f/7f mynx control vascular closure device (vcd) to stop bleeding, but it failed because the white tube tip was damaged and did not enter the unknown sheath.There was no reported patient injury.The device was used after a percutaneous coronary intervention (pci).Multiple attempts to obtain additional information were made without success.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, and the sealant remained in its manufactured position fully covered by the sealant outer sleeve assembly which did not show any evidence or traces of a frayed/split/torn condition as received.Nevertheless, exposure to blood was denoted during this unaided eye visual inspection.No other damages/anomalies were observed with the returned device during visual inspection.Neither the syringe, nor the sheath used were returned with the device reported.Per dimensional analysis, the slit length was verified and noted to be within specification.Per microscopic analysis, visual inspection at high magnification showed that the sealant sleeves were in their manufactured position with no signs of damage noted.However, the distal portion of the sealant was swollen from exposure to blood and protruding beyond the sealant sleeves.This is likely related to premature blood exposure as evidenced by the fact that buttons 1 and 2 were not depressed.Per functional analysis, an applicable cordis lab catheter sheath introducer (csi) was used for a functional insertion/withdrawal test, and there was no resistance or friction perceived during this analysis when the device was passed through the csi.The functional deployment mechanism test was executed due to a premature protrusion of the sealant that was appreciated only in the magnified visual inspection.The reported event of ¿sealant sleeves (cartridge assembly)-damaged¿ was not confirmed through analysis of the returned device since there were no traces of damage noted to the component.However, a condition was noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ due to the premature exposure observed related to the swelling sealant protruding beyond the sealant sleeves.The exact cause of the observed condition could not be conclusively determined during analysis.Based on the limited 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 possibly contributed to the premature exposure/swelling 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 instructions for use (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 failure observed 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: 18365882
• MDR Text Key: 331008289
• Report Number: 3004939290-2023-03542
• 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: 01/08/2024

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: MX6760E
• Device Lot Number: F2222102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 12/28/2023
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2022
• 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: UNKNOWN SHEATH.