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

Catalog Number MX5060E

Device Problems Decrease in Pressure (1490); Material Rupture (1546)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2024

Event Type  malfunction  

Event Description

As reported, sterile heparin saline leaked from the balloon of a 5f mynx control vascular closure device (vcd) during preparation and the ballon ruptured.There was no reported patient injury.The device was prepared and stored according to the instructions for use, and no damage was observed prior to opening the package.The device will be returned for analysis.

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, sterile heparin/saline leaked from the balloon of a 5f mynx control vascular closure device (vcd) during preparation and the balloon ruptured.There was no reported patient injury.The device was prepared and stored according to the instructions for use, and no damage was observed prior to opening the package.The deployer was certified in the use of the mynx device.Hemostasis was achieved with the use of another mynx device.The device was returned; however, not received for analysis.The reported event of ¿balloon-balloon loss of pressure¿ could not be confirmed as the device was not received for analysis.The exact cause of the issue experienced could not be determined.Based on the limited information available for review, it is not possible to determine what factors may have contributed to the loss of pressure reported.However, balloon prep and/or handling factors are possible.According to the instructions for use (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.¿ based on the information available for review, there is no indication that the event is related to the design or manufacturing process of the unit.Therefore, no corrective/preventative action will be taken at this time.

Event Description

As reported, sterile heparin saline leaked from the balloon of a 5f mynx control vascular closure device (vcd) during preparation and the ballon ruptured.There was no reported patient injury.The device was prepared and stored according to the instructions for use, and no damage was observed prior to opening the package.The deployer was certified in the use of the mynx device.Hemostasis was achieved with the use of another mynx device.The device was returned, however not received for analysis.

Event Description

As reported, sterile heparin saline leaked from the balloon of a 5f mynx control vascular closure device (vcd) during preparation and the ballon ruptured.There was no reported patient injury.The device was prepared and stored according to the instructions for use, and no damage was observed prior to opening the package.The deployer was certified in the use of the mynx device.Hemostasis was achieved with the use of another mynx device.

Manufacturer Narrative

B5.As reported, sterile heparin saline leaked from the balloon of a 5f mynx control vascular closure device (vcd) during preparation and the ballon ruptured.There was no reported patient injury.The device was prepared and stored according to the instructions for use, and no damage was observed prior to opening the package.The deployer was certified in the use of the mynx device.Hemostasis was achieved with the use of another mynx device.

• 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: 18684844
• MDR Text Key: 335116703
• Report Number: 3004939290-2024-00068
• 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
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 04/04/2024

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 Number: MX5060E
• Device Lot Number: F2222404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/16/2024
• Initial Date FDA Received: 02/12/2024
• Supplement Dates Manufacturer Received: 01/16/2024; 04/02/2024
• Supplement Dates FDA Received: 02/12/2024; 04/04/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/15/2022
• 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.