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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH SANTA CLARA MYNX CONTROL; DEVICE, HEMOSTASIS, VASCULAR
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CARDINAL HEALTH SANTA CLARA MYNX CONTROL; DEVICE, HEMOSTASIS, VASCULAR Back to Search Results
Catalog Number MX5060E
Device Problems Decrease in Pressure (1490); Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2024
Event Type  malfunction  
Event Description
As reported, the balloon of a 5f mynx control vascular closure device (vcd) burst during the "ballooning process".There was no reported patient injury.The device was intended for use in a trans-arterial chemo embolization procedure.The device is being returned for evaluation.
 
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 balloon of a 5f mynx control vascular closure device (vcd) burst during the "ballooning process".There was no reported patient injury.The device was intended for use in a trans-arterial chemo embolization procedure.Additional information was requested but not provided.A non-sterile ¿mynx control vcd 5f¿ 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 syringe was received connected to the device, and the procedural sheath was not received for evaluation.The stopcock was observed in the open position, and the balloon was found fully deflated.In addition, the sealant was found in its manufactured position fully covered by the sealant sleeves, the sealant was not exposed to blood.In addition, no damages were observed to the sealant sleeves assembly.Per functional analysis, an inflation/deflation test was performed on the balloon of the returned device; and during this evaluation, the balloon was fully inflated with pressure maintained.The balloon was able to be inflated/deflated with proper functioning of the inflation indicator as intended per the mynx control instructions for use (ifu).The reported event of ¿balloon-balloon loss of pressure¿ was not confirmed through analysis of the returned device since the balloon passed functional analysis.The exact cause of the reported incident could not be conclusively determined during analysis of the returned device.Based on the limited information available for review and the product analysis, it is not possible to determine what factors may have contributed to the issue experienced since there was no burst noted.However, balloon prep and/or handling factors are possible.Although not intended as a mitigation, the mynx control ifu instructs users to purge the device of air by drawing vacuum with 2-3 ml of sterile saline prior to use.It also states to check for air bubbles in the balloon.If air bubbles are visible, deflate the balloon, draw vacuum to remove bubbles and re-inflate.Failure to purge the device of air during the prep phase and/or excessive tension applied to the catheter during pullback can cause the balloon to partially collapse as the air in the system is exposed to additional compressive forces and cause the balloon to be pulled through the arteriotomy, which can be mistaken as a balloon rupture.Neither the product analysis, nor the information available for review suggest that the reported failure could be related to the design or manufacturing process of the unit.Therefore, no corrective/preventative actions will be taken at this time.
 
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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 Key19051277
MDR Text Key340336604
Report Number3004939290-2024-00164
Device Sequence Number1
Product Code MGB
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
P040044
Number of Events Reported1
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 04/05/2024
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 Catalogue NumberMX5060E
Device Lot NumberF2308202
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/01/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 03/12/2024
Initial Date FDA Received04/05/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured03/23/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
UNKNOWN.
Patient EthnicityNon Hispanic
Patient RaceAsian
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