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

Catalog Number MX6760E

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 is available for analysis, but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the white tube tip of a 6/7f mynx control vascular closure device (vcd) was damaged and did not enter the sheath.There was no reported patient injury.The vcd was used after completing a trans femoral cerebral angiogram to stop the bleeding, but it failed.Additional information was requested but not provided.The device was not returned for evaluation as previously requested.Addendum: on product evaluation the sealant was only partially covered by the sealant sleeves.

Manufacturer Narrative

As reported, the white tube tip of a 6f/7f mynx control vascular closure device (vcd) was damaged and did not enter the sheath.There was no reported patient injury.The vcd was used after completing a transfemoral cerebral angiogram to stop the bleeding, but it failed.Additional information was requested but not provided.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 the button 1 and button 2 were not depressed, and the sealant remained in its manufactured position partially covered by the sealant outer sleeve assembly.The sealant outer sleeve assembly showed evidence of a split condition that could be related to the reported event as received during this unaided eye visual inspection.No other damages/anomalies were observed on the returned device during the unaided eye visual inspection.Neither the syringe nor the sheath was returned with the device to be evaluated.Per dimensional analysis, the slit length could not be measured due to the condition observed in the device as received where the sealant sleeves showed evidence of a split condition.Per functional analysis, an applicable cordis lab catheter sheath introducer (csi) was used for a functional insertion/withdrawal test in which resistance was not perceived when the attempt to pass the device through the csi was executed.The functional deployment mechanism test was executed due to the observed split condition of the sealant sleeve.The result for this functional test was the correct activation of the deployment mechanism and the retraction of the balloon.Per microscopic analysis, visual inspection at high magnification showed that the sealant outer sleeve assembly showed that the sealant sleeves presented a split condition that could be related to the reported event.The reported event of ¿sealant sleeves (cartridge assembly)-damaged¿ was confirmed through analysis of the returned device as the sealant sleeve assembly had a split condition observed.Additionally, a condition was noted in the returned device of ¿mynx control system-deployment difficulty-premature¿ due to the partially exposed sealant from the damaged sleeves.The exact cause of the observed conditions 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 (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/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 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 95054 ; 7863138372
• MDR Report Key: 18451391
• MDR Text Key: 332731769
• Report Number: 3004939290-2024-00009
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/30/2024

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 Expiration Date: 08/31/2024
• 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: 12/11/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 01/25/2024
• Supplement Dates FDA Received: 01/30/2024
• 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; UNKNWON SHEATH