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 08/28/2023

Event Type  malfunction  

Event Description

As reported, the sealant sleeves containing the polymer on a 6/7f mynx control vascular closure device, cracked while attempting to insert the vcd into an unknown sheath.It was attempted to be inserted exactly parallel into the procedural sheath.There was no reported patient injury.The device was stored and prepped per the instructions for use (ifu).The user was trained in the use of the mynx device.The vcd was used with a non-cordis sheath.The device is being returned for evaluation.Addendum: product analysis demonstrates that the sealant is 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.

Manufacturer Narrative

As reported, the sealant sleeves containing the polymer on a 6/7f mynx control vascular closure device (vcd), cracked while attempting to insert it into an unknown sheath.The user attempted to insert the vcd exactly parallel into the procedural sheath.There was no reported patient injury.The device was stored and prepped per the instructions for use (ifu).The user was trained in the use of the mynx device.The vcd was used with a non-cordis sheath.A non-sterile ¿mynx control vcd, 6f/7f¿ was returned for evaluation.Visual inspection revealed button #1 and button #2 were not depressed.The procedure sheath was not returned for analysis.The syringe was connected to the device.The stopcock was set on the opened position.The balloon was not inflated.The sealant was in the manufacturing position saturated in blood.The sealant sleeves presented with a severely kinked condition.The sealant was exposed.The atraumatic tip did not present with any damages or anomalies.The slit length could not be verified due to the observed kink.The catheter usable length was measured and found within specification.A simulated deployment test was performed.The tension indicator was aligned manually.Buttons 1 and 2 were able to be depressed to deploy the sealant and withdraw the balloon with no resistance felt.No issues were noted with respect to both buttons 1 and 2 deployment.The returned device performed as intended per the mynx control ifu (the unit was cleaned up to remove all blood and saline solution after the deployment).The sealant assembly was inspected using a vision system.The kinked condition on the sleeves and the exposed sealant were confirmed.The reported ¿sealant sleeves (cartridge assembly)-cracked¿ was not confirmed.The cartridge assembly did not present with a cracked condition.However, the malfunction ¿mynx control system-deployment difficulty-premature¿, was confirmed due to the exposed sealant from the kinked/bent condition of the sealant sleeves.The exact cause of the observed condition could not be conclusively determined during the analysis.Based on the information available for review and product analysis, procedural/handling factors and/or the condition of the sheath (although not returned) may have 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 sealant is placed right under the outer sleeve assembly and is protected from exposing prematurely.The outer sleeve is assembled with 2 side slit overlapping outer sleeves.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, that 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.¿ the product analysis does not suggest 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: 18326628
• MDR Text Key: 330499135
• Report Number: 3004939290-2023-03535
• 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: 12/19/2023

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: F2317301
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2023
• 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: 12/14/2023
• Supplement Dates Manufacturer Received: 12/18/2023
• Supplement Dates FDA Received: 12/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2023
• 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: 5-7FR SHEATH.