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

Catalog Number MX6760

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

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

Event Date 09/19/2023

Event Type  malfunction  

Event Description

As reported, the balloon of a 6/7f mynx control vascular closure device (vcd) popped after insertion.Another mynx device was used for hemostasis.There was no reported patient injury.The issue may be related to calcification.The device was discarded.The device was used in an interventional procedure using a retrograde approach.The deployer was mynx certified.The vcd was used with a non-cordis 6f sheath.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5 mm in diameter.There was moderate vessel tortuosity.There was moderate presence of pvd/ calcium in the vicinity of the puncture site.The vcd was stored properly according to the ifu.There was no prior pta, stent, or vascular graft in the common femoral artery or vein.The balloon lost pressure when attempting to inflate in the arteriotomy.The device is not being returned for evaluation as it was discarded.

Manufacturer Narrative

Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

As reported, the balloon of a 6f/7f mynx control vascular closure device (vcd) popped after insertion.Another mynx device was used for hemostasis.There was no reported patient injury.The issue may be related to calcification.The device was used in an interventional procedure using a retrograde approach.The deployer was mynx certified.The vcd was used with a non-cordis 6f sheath.The femoral artery¿s suitability was verified on angiography, including the insertion angle (30-45 degrees) of the vascular sheath introducer.The vessel diameter was verified to be greater than or equal to 5mm in diameter.There was moderate vessel tortuosity.There was moderate presence of peripheral vascular disease (pvd)/ calcium in the vicinity of the puncture site.The vcd was stored properly according to the instructions for use (ifu).There was no prior pta, stent, or vascular graft in the common femoral artery or vein.The balloon lost pressure when attempting to inflate in the arteriotomy.The device is not being returned for evaluation as it was discarded.The reported event of ¿balloon-balloon loss of pressure¿ could not be confirmed as the device was not returned for analysis.The exact cause of the issue experienced could not be determined.Based on the information available for review, access site vessel characteristics (moderate presence of pvd/calcium in the vicinity of the puncture site) and/or sheath condition factors are possible since calcification/pvd at the access site or a frayed/damaged sheath tip can cause damage to the balloon, resulting in a loss of pressure.According to the mynx control ifu, which is not intended as a mitigation, ¿the safety and effectiveness of the mynx control vcd have not been established in the following patient populations: patients with clinically significant peripheral vascular disease in the vicinity of the puncture.¿ also stated in the ifu during product preparation, ¿confirm via femoral arteriogram prior to using the mynx control vcd: common femoral artery single wall puncture.Evidence of adequate flow.No evidence of significant pvd in the vicinity of the puncture.¿ additionally, users are instructed to discard the device if the balloon does not maintain pressure.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.

• 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 Key: 17936938
• MDR Text Key: 325703614
• Report Number: 3004939290-2023-03422
• 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: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2023
• 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: F2312401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2023
• 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: BSX 6F SHEATH.
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 100 KG