Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CARDINAL HEALTH SANTA CLARA MYNX CONTROL; DEVICE, HEMOSTASIS, VASCULAR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 10/05/2023
Event Type  malfunction  
Event Description
As reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured during prep.There was no reported patient injury.Hemostasis was achieved by manual compression for 20 minutes.The device was trying to use after an interventional peripheral procedure using a retrograde approach.The physician was being trained on using the device.The device was stored according to the instructions for use (ifu).The device storage temperature did not exceed 25 °c.The mynx vcd was prepped according to ifu instructions.The syringe provided was used to inflate the balloon.The balloon was inflated with 3ml of saline.The device looked okay after removing from the package.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel type was femoral arterial.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was presence of calcium in the vicinity of the puncture site.A 5f non-cordis sheath was being used.The device will be 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) ruptured during prep.There was no reported patient injury.Hemostasis was achieved by manual compression for 20 minutes.The device was trying to use after an interventional peripheral procedure using a retrograde approach.The physician was being trained on using the device.The device was stored according to the instructions for use (ifu).The device storage temperature did not exceed 25 °c.The mynx vcd was prepped according to ifu instructions.The syringe provided was used to inflate the balloon.The balloon was inflated with 3ml of saline.The device looked okay after removing from the package.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel type was femoral arterial.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was presence of calcium in the vicinity of the puncture site.A 5f non-cordis sheath was being used.A non-sterile ¿mynx control vcd, 5f (ce mark)¿ was returned for investigation.Per visual analysis, the unit was thoroughly inspected observing that both button 1 and button 2 were not depressed.The syringe and the sheath were returned for analysis.The stopcock was set in the open position.The sealant remained in its manufactured position and was not exposed.The atraumatic tip did not present any damages or anomalies.The device was blood-saturated.No other outstanding details were noticed.Per functional analysis, inflation/deflation test was performed on the returned device to ensure the balloon¿s functionality according to the instructions for use (ifu).The results revealed a leak in the balloon.The balloon was inspected using a vision system to obtain a magnified image.A pin hole was confirmed.The reported event of ¿balloon-balloon loss of pressure¿ was confirmed through analysis of the returned device.However, the exact cause of the pin hole found could not be conclusively determined during analysis.Based on the information available for review and product analysis, it is not possible to determine what factors may have contributed to the issue reported.However, as this issue was found during preparation of the device, handling factors during prep are possible.According to the ifu during the prepare balloon step, which is not intended as a mitigation, ¿fill locking syringe with 2 to 3 ml of sterile saline, attach to stopcock and draw vacuum.Check luer connector and tighten if necessary.Inflate the balloon until the black marker on the inflation indicator is fully visible.Check for leaks in the balloon and syringe connector; retighten if necessary.Discard the device if the balloon does not maintain pressure.Check for air bubbles in the balloon.If air bubbles are visible, deflate the balloon, draw vacuum to remove bubbles and re-inflate.¿ 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.
 
Event Description
As reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured during prep.There was no reported patient injury.Hemostasis was achieved by manual compression for 20 minutes.The device was trying to use after an interventional peripheral procedure using a retrograde approach.The physician was being trained on using the device.The device was stored according to the instructions for use (ifu).The device storage temperature did not exceed 25 °c.The mynx vcd was prepped according to ifu instructions.The syringe provided was used to inflate the balloon.The balloon was inflated with 3ml of saline.The device looked okay after removing from the package.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel type was femoral arterial.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was presence of calcium in the vicinity of the puncture site.A 5f non-cordis sheath was being used.The device will be returned for evaluation.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
MDR Report Key18145934
MDR Text Key328388603
Report Number3004939290-2023-03493
Device Sequence Number1
Product Code MGB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040044 MGB
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,Followup
Report Date 12/21/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Catalogue NumberMX5060E
Device Lot NumberF2316601
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/14/2023
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received12/08/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2023
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
5F TERUMO SHEATH (INTRODUCER2).
-
-