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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
Model Number N/A
Device Problems Decrease in Pressure (1490); Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/28/2024
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.Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured during the procedure.Hemostasis was achieved by manual compression for twenty minutes.There was no reported patient injury.The mynx vcd was prepped according to the instructions for use (ifu).The device was attempted to be used after an interventional coronary procedure using a retrograde approach.The physician was being trained on using the device.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.A 5f non cordis sheath was used.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.The device will be returned for evaluation.
 
Manufacturer Narrative
After further review of additional information received the following sections have been updated accordingly: b5, g3, g6, h2, h3, and h11.Additional information is pending and will be submitted within 30 days upon receipt.
 
Event Description
As reported, the balloon of a 5f mynx control vascular closure device (vcd) ruptured during the procedure.Hemostasis was achieved by manual compression for twenty minutes.There was no reported patient injury.The mynx vcd was prepped according to the instructions for use (ifu).The device was attempted to be used after an interventional coronary procedure using a retrograde approach.The physician was being trained on using the device.The femoral artery¿s suitability was verified on angiography or venography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.A 5f non cordis sheath was used.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.The device will be returned for evaluation.
 
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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 Key19176816
MDR Text Key341019625
Report Number3004939290-2024-00203
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 04/24/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/24/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberMX5060E
Device Lot NumberF2402202
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/16/2024
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/03/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/22/2024
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 INTRODUCER2 (BY TERUMO)
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